A Study to Assess the Efficacy and Safety of Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease (ARRIVE)

September 26, 2018 updated by: Bayer

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel Group Study to Assess the Efficacy (Reduction of Cardiovascular Disease Events) and Safety of 100 mg Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease

The use of acetylsalicylic acid in the primary prevention of cardiovascular events has been extensively studied but to a lesser extent in patients with moderate levels of cardiovascular risk. The current study is designed to prove the efficacy and tolerability of 100 mg enteric-coated Aspirin versus placebo in the prevention of cardiovascular disease (CVD) events, which include fatal and nonfatal myocardial infarction, fatal and nonfatal stroke and CV death, in a population with no history of known CVD who are at moderate risk of major CHD events (approximately 10-20% 10 year CHD risk). This corresponds to a patient population mean 10-year CVD risk of approximately 30%. Subjects are treated in a standard care setting and may receive treatment for the underlying risk factors as defined by the treating physician. Outcome events will be adjudicated by an Endpoint Adjudication Committee and the study will be monitored by an independent Data Safety Monitoring Board.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Summary of substantial Protocol amendments

Amendment #2 from 09-APR-2008:

  • Systolic blood pressure (SBP) limit of 170 mmHg has been added to the exclusion criteria
  • Exclusion of patients currently taking anticoagulant medication
  • A longer interval between the daily dose of study drug and ibuprofen
  • Revised wording in moderate risk definitions for coronary heart disease (CHD) and cerebrovascular disease (CVD): "To evaluate the clinical effects of a 100 mg/day enteric-coated acetylsalicylic acid versus placebo in the reduction of CVD events in patients at moderate risk of major CHD events (approximately 10 to 20% 10-year CHD risk; approximately 20 to 30% 10-year risk of CVD). This corresponds to a patient population mean 10-year CVD risk of approximately 30%."

Amendment #3 from 02-JAN-2009

• Increase in the number of allowed risk factors for males, age is no longer a risk factor

Amendment #4 from 02-OCT-2013

  • The primary endpoint is changed to include confirmed UA and TIA.
  • The estimated event rate is changed to 1.5% per year due to new information.
  • Effect size (risk reduction) changed from 14.9% to 17 to 18%.
  • Achieving 60,000 person-years instead of 1488 primary endpoint events
  • Additional treatment and follow-up for a maximum of another 12 months.
  • Change to reduced adverse event and concomitant therapy reporting

Study Type

Interventional

Enrollment (Actual)

12546

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10249
      • Berlin, Germany, 13055
      • Berlin, Germany, 14050
      • Berlin, Germany, 12099
      • Berlin, Germany, 10407
      • Berlin, Germany, 13057
      • Berlin, Germany, 13405
      • Berlin, Germany, 13467
      • Daaden, Germany, 57567
      • Hamburg, Germany, 22177
      • Hamburg, Germany, 22041
      • Hamburg, Germany, 22143
      • Hamburg, Germany, 22299
      • Hamburg, Germany, 22335
      • Rehburg-Loccum, Germany, 31547
      • Riede, Germany, 27339
      • Thedinghausen, Germany, 27321
    • Baden-Württemberg
      • Benningen, Baden-Württemberg, Germany, 71726
      • Deggingen, Baden-Württemberg, Germany, 73326
      • Dossenheim, Baden-Württemberg, Germany, 69221
      • Ettlingen, Baden-Württemberg, Germany, 78275
      • Graben-Neudorf, Baden-Württemberg, Germany, 76676
      • Heilbronn, Baden-Württemberg, Germany, 74080
      • Hockenheim, Baden-Württemberg, Germany, 68766
      • Ludwigsburg, Baden-Württemberg, Germany, 71640
      • Schwetzingen, Baden-Württemberg, Germany, 68723
      • Sinzheim, Baden-Württemberg, Germany, 76547
      • Stockach, Baden-Württemberg, Germany, 78333
      • Stuttgart, Baden-Württemberg, Germany, 70378
      • Trossingen, Baden-Württemberg, Germany, 78647
      • Weinheim, Baden-Württemberg, Germany, 69469
    • Bayern
      • Arzberg, Bayern, Germany, 95659
      • Bergrheinfeld, Bayern, Germany, 97493
      • Dinkelsbühl, Bayern, Germany, 91550
      • Gars, Bayern, Germany, 83536
      • Hohenau, Bayern, Germany, 94545
      • Künzing, Bayern, Germany, 94550
      • München, Bayern, Germany, 80336
      • Oberaurach, Bayern, Germany, 97514
      • Sand Am Main, Bayern, Germany, 97522
      • Schrobenhausen, Bayern, Germany, 86529
      • Spalt, Bayern, Germany, 91174
      • Strasskirchen, Bayern, Germany, 94342
      • Sulzbach-Rosenberg, Bayern, Germany, 92237
      • Ursensollen, Bayern, Germany, 92289
    • Brandenburg
      • Cottbus, Brandenburg, Germany, 03046
      • Elsterwerda, Brandenburg, Germany, 04910
      • Gransee, Brandenburg, Germany, 16775
      • Ketzin, Brandenburg, Germany, 14669
      • Potsdam, Brandenburg, Germany, 14778
    • Hessen
      • Frankfurt, Hessen, Germany, 65929
      • Frankfurt, Hessen, Germany, 60599
      • Hanau, Hessen, Germany, 63450
      • Kelkheim, Hessen, Germany, 65779
      • Rotenburg, Hessen, Germany, 36199
      • Wetter, Hessen, Germany, 35083
    • Niedersachsen
      • Aurich, Niedersachsen, Germany, 26603
      • Bockenem, Niedersachsen, Germany, 31167
      • Braunschweig, Niedersachsen, Germany, 38100
      • Horneburg, Niedersachsen, Germany, 21640
      • Jühnde, Niedersachsen, Germany, 37127
      • Loxstedt, Niedersachsen, Germany, 27612
      • Nienburg, Niedersachsen, Germany, 31582
      • Northeim, Niedersachsen, Germany, 37154
      • Papenburg, Niedersachsen, Germany, 26871
      • Stuhr, Niedersachsen, Germany, 28816
      • Wardenburg, Niedersachsen, Germany, 26203
      • Weyhe, Niedersachsen, Germany, 28844
      • Winsen, Niedersachsen, Germany, 21423
    • Nordrhein-Westfalen
      • Aachen, Nordrhein-Westfalen, Germany, 52074
      • Aachen, Nordrhein-Westfalen, Germany, 52080
      • Arnsberg, Nordrhein-Westfalen, Germany, 59757
      • Bad Lippspringe, Nordrhein-Westfalen, Germany, 33175
      • Bad Salzuflen, Nordrhein-Westfalen, Germany, 32105
      • Bad Salzuflen, Nordrhein-Westfalen, Germany, 32108
      • Bad Sassendorf, Nordrhein-Westfalen, Germany, 59505
      • Bergkamen, Nordrhein-Westfalen, Germany, 59192
      • Bochum, Nordrhein-Westfalen, Germany, 44797
      • Dortmund, Nordrhein-Westfalen, Germany, 44139
      • Dortmund, Nordrhein-Westfalen, Germany, 44328
      • Dortmund, Nordrhein-Westfalen, Germany, 44339
      • Duisburg, Nordrhein-Westfalen, Germany, 47199
      • Essen, Nordrhein-Westfalen, Germany, 45136
      • Essen, Nordrhein-Westfalen, Germany, 45355
      • Essen, Nordrhein-Westfalen, Germany, 45130
      • Essen, Nordrhein-Westfalen, Germany, 45276
      • Essen, Nordrhein-Westfalen, Germany, 45359
      • Freudenberg, Nordrhein-Westfalen, Germany, 57258
      • Greven, Nordrhein-Westfalen, Germany, 48268
      • Hamm, Nordrhein-Westfalen, Germany, 59069
      • Hünxe, Nordrhein-Westfalen, Germany, 46569
      • Kamp-Lintfort, Nordrhein-Westfalen, Germany, 47475
      • Krefeld, Nordrhein-Westfalen, Germany, 47798
      • Köln, Nordrhein-Westfalen, Germany, 51069
      • Langenfeld, Nordrhein-Westfalen, Germany, 40764
      • Lienen, Nordrhein-Westfalen, Germany, 49536
      • Lippetal, Nordrhein-Westfalen, Germany, 59510
      • Löhne, Nordrhein-Westfalen, Germany, 32584
      • Marl, Nordrhein-Westfalen, Germany, 45770
      • Münster, Nordrhein-Westfalen, Germany, 48167
      • Netphen, Nordrhein-Westfalen, Germany, 57250
      • Porta Westfalica, Nordrhein-Westfalen, Germany, 32457
      • Remscheid, Nordrhein-Westfalen, Germany, 42897
      • Siegen, Nordrhein-Westfalen, Germany, 57072
      • Viersen, Nordrhein-Westfalen, Germany, 41751
      • Welver, Nordrhein-Westfalen, Germany, 59514
      • Wetter, Nordrhein-Westfalen, Germany, 58300
      • Witten, Nordrhein-Westfalen, Germany, 58455
    • Rheinland-Pfalz
      • Kallstadt, Rheinland-Pfalz, Germany, 67169
      • Ludwigshafen, Rheinland-Pfalz, Germany, 67063
      • Mainz, Rheinland-Pfalz, Germany, 55116
      • Mainz, Rheinland-Pfalz, Germany, 55127
      • Nassau, Rheinland-Pfalz, Germany, 56377
      • Rhaunen, Rheinland-Pfalz, Germany, 55624
      • Speyer, Rheinland-Pfalz, Germany, 67346
    • Sachsen
      • Beucha, Sachsen, Germany, 04824
      • Borna, Sachsen, Germany, 04552
      • Delitzsch, Sachsen, Germany, 04509
      • Dresden, Sachsen, Germany, 01277
      • Dresden, Sachsen, Germany, 01069
      • Dresden, Sachsen, Germany, 01127
      • Leipzig, Sachsen, Germany, 04103
      • Leipzig, Sachsen, Germany, 04249
      • Markkleeberg, Sachsen, Germany, 04416
      • Meißen, Sachsen, Germany, 01662
      • Oberwiesenthal, Sachsen, Germany, 09484
      • Riesa, Sachsen, Germany, 01587
      • Wermsdorf, Sachsen, Germany, 04779
    • Sachsen-Anhalt
      • Bitterfeld, Sachsen-Anhalt, Germany, 06749
      • Halle, Sachsen-Anhalt, Germany, 06124
      • Magdeburg, Sachsen-Anhalt, Germany, 39104
    • Schleswig-Holstein
      • Bad Bramstedt, Schleswig-Holstein, Germany, 24576
      • Reinfeld, Schleswig-Holstein, Germany, 23858
    • Thüringen
      • Apolda, Thüringen, Germany, 99510
      • Blankenhain, Thüringen, Germany, 99444
      • Grimma, Thüringen, Germany, 04668
  • Ireland
      • Cork, Ireland
      • Dublin, Ireland, 2
    • Cork
      • Bishopstown, Cork, Ireland
    • Limerick
      • Kilmallock, Limerick, Ireland
      • Rathkeale, Limerick, Ireland
    • Waterford
      • Tallow, Waterford, Ireland
    • Wexford
      • Enniscorthy, Wexford, Ireland
      • Gorey, Wexford, Ireland
    • Wicklow
      • Bray, Wicklow, Ireland
  • Italy
      • Asti, Italy, 14100
      • Bergamo, Italy, 24128
      • Reggio Emilia, Italy, 42123
    • Abruzzo
      • Chieti, Abruzzo, Italy, 66100
    • Ascoli Piceno
      • Amandola, Ascoli Piceno, Italy, 63021
    • Campania
      • Napoli, Campania, Italy, 80131
    • Emilia-Romagna
      • Reggio Emilia, Emilia-Romagna, Italy, 42019
    • Genova
      • Chiavari, Genova, Italy, 16043
    • Lazio
      • Roma, Lazio, Italy, 00161
      • Roma, Lazio, Italy, 00157
    • Lombardia
      • Como, Lombardia, Italy, 22066
      • Varese, Lombardia, Italy, 21100
    • Milano
      • Legnano, Milano, Italy, 20025
    • Piemonte
      • Novara, Piemonte, Italy, 28100
      • Torino, Piemonte, Italy, 10023
    • Puglia
      • Foggia, Puglia, Italy, 71100
    • Sicilia
      • Catania, Sicilia, Italy, 95124
    • Torino
      • Chieri, Torino, Italy, 10023
      • Moncalieri, Torino, Italy, 10024
    • Toscana
      • Grosseto, Toscana, Italy, 58100
  • Poland
      • Bialystok, Poland, 15-183
      • Bydgoszcz, Poland
      • Bydgoszcz, Poland, 85-863
      • Chrzanow, Poland
      • Czechowice-Dziedzice, Poland
      • Elblag, Poland, 82-300
      • Gdansk, Poland, 80-286
      • Gdansk, Poland, 80-461
      • Gdansk, Poland, 80-822
      • Gdynia, Poland, 81-317
      • Gliwice, Poland, 44-109
      • Grodzisk Mazowiecki, Poland, 05-825
      • Katowice, Poland, 40-752
      • Katowice, Poland, 40-226
      • Krakow, Poland
      • Krakow, Poland, 31-011
      • Krakow, Poland, 31-156
      • Krakow, Poland, 30-424
      • Krakow, Poland, 31-567
      • Krakow, Poland, 31-637
      • Kutno, Poland, 99-300
      • Lancut, Poland
      • Linia, Poland, 84-223
      • Lodz, Poland
      • Lublin, Poland
      • Lublin, Poland, 20-044
      • Lublin, Poland, 20-258
      • Malaszewicze, Poland
      • Malbork, Poland, 82-200
      • Naklo nad Notecia, Poland, 98-100
      • Olkusz, Poland
      • Ostrow Wielkopolski, Poland, 63-400
      • Poznan, Poland, 60-539
      • Przeworsk, Poland, 37-200
      • Radom, Poland, 26-600
      • Skierniewice, Poland
      • Skierniewice, Poland, 96-100
      • Sobotka, Poland
      • Sopot, Poland, 81-746
      • Szczyrk, Poland, 43-370
      • Wabrzezno, Poland
      • Warszawa, Poland, 01-192
      • Warszawa, Poland, 02-507
      • Warszawa, Poland, 02-796
      • Wejherowo, Poland
      • Wloclawek, Poland
      • Wola, Poland
      • Wroclaw, Poland, 50-127
      • Wroclaw, Poland, 51-112
      • Zabrze, Poland
  • Puerto Rico
      • Guaynabo, Puerto Rico, 00968
      • Manati, Puerto Rico, 00674
      • Orocovis, Puerto Rico, 00720
      • San Juan, Puerto Rico, 00918
      • Trujilo Alto, Puerto Rico, 00976
  • Spain
      • Albacete, Spain, 2260
      • Alicante, Spain, 03007
      • Badajoz, Spain, 06140
      • Barcelona, Spain, 08025
      • Barcelona, Spain, 08023
      • Barcelona, Spain, 08017
      • Huelva, Spain, 21003
      • León, Spain
      • León, Spain, 24001
      • Lugo, Spain, 27770
      • Madrid, Spain, 28003
      • Madrid, Spain, 28030
      • Madrid, Spain, 28032
      • Murcia, Spain, 30008
      • Murcia, Spain, 300005
      • Murcia, Spain, 30007
      • Salamanca, Spain, 27-31
      • Santander, Spain, 39009
      • Valladolid, Spain, 47007
    • A Coruña
      • Sobrado Dos Monxes, A Coruña, Spain, 15813
    • Albacete
      • La Roda, Albacete, Spain, 06230
    • Alicante
      • Benidorm, Alicante, Spain, 03503
      • Elche, Alicante, Spain
      • Petrer, Alicante, Spain, 03610
      • Xixona, Alicante, Spain, 03100
    • Asturias
      • Oviedo, Asturias, Spain, 33013
      • Oviedo, Asturias, Spain, 33009
      • Posada De Llanes, Asturias, Spain, 33594
    • Catalunya
      • Vic (Barcelona), Catalunya, Spain, 08500
    • Lugo
      • Begonte, Lugo, Spain, 27373
      • Viveiro, Lugo, Spain, 27850
    • Murcia
      • Espinardo, Murcia, Spain, 30100
    • Ourense
      • Orense, Ourense, Spain, 32003
    • Santa Cruz De Tenerife
      • Gümar, Santa Cruz De Tenerife, Spain, 38591
      • La Victoria, Santa Cruz De Tenerife, Spain, 38380
    • Tarragona
      • Alcover, Tarragona, Spain, 43460
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZD
      • Airedire, United Kingdom, ML66DB
      • Antrim, United Kingdom, BT38 9TG
      • Bath, United Kingdom, BA11 2FH
      • Bath, United Kingdom, BA2 4JT
      • Belfast, United Kingdom
      • Belfast, United Kingdom, BT1 2JR
      • Belfast, United Kingdom, BT12 5EY
      • Belfast, United Kingdom, BT12 5LT
      • Belfast, United Kingdom, BT13 3BW
      • Belfast, United Kingdom, BT15 2GE
      • Belfast, United Kingdom, BT5 7BP
      • Belfast, United Kingdom, BT8 6GR
      • Bellshill, United Kingdom, ML4 1PS
      • Blantyre, United Kingdom, G72 0BS
      • Cardiff, United Kingdom, CF5 4AD
      • Coatrbridge, United Kingdom, ML5 3BJ
      • Crossgar, United Kingdom, BT30 9JU
      • Doncaster, United Kingdom, DN1 2EU
      • Dundee, United Kingdom, DD19SY
      • Glasgow, United Kingdom, G21 1TR
      • Glasgow, United Kingdom, G5 0BQ
      • Glasgow, United Kingdom, G52 3QN
      • Glasgow, United Kingdom, G67 1BJ
      • Hamilton, United Kingdom, ML3 7EN
      • Hamilton, United Kingdom, ML3 8AA
      • Inverness, United Kingdom, IV2 4AG
      • Ipswich, United Kingdom, IP4 2PU
      • Lockerbie, United Kingdom, D11 2BJ
      • London, United Kingdom, SW12 8EU
      • Manchester, United Kingdom, M13 9WL
      • New Stevenson, United Kingdom, ML1 4LT
      • Paisley, United Kingdom
      • Peterborough, United Kingdom, PE8 6PL
      • Thornhill, United Kingdom, DG3 5AA
      • Watford, United Kingdom, WD25 7NL
      • Wishaw, United Kingdom, ML2 7BQ
      • Witley Bay, United Kingdom, NE26 1NA
    • Antrim
      • Ballymena, Antrim, United Kingdom, BT42 4JP
      • Ballymena, Antrim, United Kingdom, BT43 6JD
      • Crumlin, Antrim, United Kingdom, BT29 4LP
      • Newtonabbey, Antrim, United Kingdom, BT37 9QU
    • Armagh
      • Craigavon, Armagh, United Kingdom, BT67 0LQ
    • Avon
      • Bath, Avon, United Kingdom, BA2 4BY
      • Bath, Avon, United Kingdom, BA2 3HT
      • Radstock, Avon, United Kingdom, BA3 2UH
    • Ayrshire
      • Irvine, Ayrshire, United Kingdom, KA12 0AY
    • Bedfordshire
      • Luton, Bedfordshire, United Kingdom, LU2 9SB
    • Berkshire
      • Slough, Berkshire, United Kingdom, SL1 1TT
    • Cambridgeshire
      • Ely, Cambridgeshire, United Kingdom, CB7 4HF
      • Ely, Cambridgeshire, United Kingdom, CB7 5SQ
      • Peterborough, Cambridgeshire, United Kingdom, PE2 5GP
      • Peterborough, Cambridgeshire, United Kingdom, PE7 3JL
    • Cheshire
      • Sandbach, Cheshire, United Kingdom, CW11 1EQ
    • Cornwall
      • Boscastle, Cornwall, United Kingdom, PL35 0BG
      • Fowey, Cornwall, United Kingdom, PL23 1DT
      • Penzance, Cornwall, United Kingdom, TR18 4JH
      • Penzance, Cornwall, United Kingdom, TR19 7HX
      • Penzance, Cornwall, United Kingdom, TR18 4EL
      • Saltash, Cornwall, United Kingdom, PL12 6DL
      • St Austell, Cornwall, United Kingdom, PL26 7RL
    • Derbyshire
      • Chesterfield, Derbyshire, United Kingdom, S40 4AA
      • Dronfield, Derbyshire, United Kingdom, S18 8QY
    • Devon
      • Plymouth, Devon, United Kingdom, PL6 7TH
    • Down
      • Carryduff, Down, United Kingdom, BT8 8HR
    • Dumfries And Galloway
      • Annan, Dumfries And Galloway, United Kingdom, DG12 6BG
    • Durham
      • Bishop Auckland, Durham, United Kingdom, DL14 6AB
      • Darlington, Durham, United Kingdom, DL2 1AA
      • Darlington, Durham, United Kingdom, DL3 7JR
      • Darlington, Durham, United Kingdom, DL3 8SQ
    • Essex
      • Leigh-on-Sea, Essex, United Kingdom, SS9 2SQ
      • Tiptree, Essex, United Kingdom, CO5 0HB
    • Fife
      • High Valleyfield, Fife, United Kingdom, KY12 8SJ
    • Glasgow City
      • Glasgow, Glasgow City, United Kingdom, G20 0XA
    • Gwynedd
      • Bangor, Gwynedd, United Kingdom, BT19 1PP
    • Hertfordshire
      • Hitchin, Hertfordshire, United Kingdom, SG4 9TH
      • Letchworth, Hertfordshire, United Kingdom, SG6 4TS
      • Letchworth, Hertfordshire, United Kingdom, SG6 4UB
    • Kent
      • Canterbury, Kent, United Kingdom, CT1 3HX
      • Chestfield, Kent, United Kingdom, CT5 3QU
      • Whitstable, Kent, United Kingdom, CT5 3SE
    • Lanarkshire
      • Carstairs, Lanarkshire, United Kingdom, ML11 8QD
      • Coatbridge, Lanarkshire, United Kingdom, ML5 3AP
      • Forth, Lanarkshire, United Kingdom, ML1 8AJ
    • Lancashire
      • Blackpool, Lancashire, United Kingdom, FY4 3AD
      • Blackpool, Lancashire, United Kingdom, FY3 7EN
      • Bolton, Lancashire, United Kingdom, BL3 6TL
      • Bolton, Lancashire, United Kingdom, BL5 3UB
    • Leicestershire
      • Hinckley, Leicestershire, United Kingdom, LE10 2SE
    • Norfolk
      • Wells-Next-The-Sea, Norfolk, United Kingdom, NR23 1JP
      • Wymondham, Norfolk, United Kingdom, NR18 0RF
    • North Ireland
      • Antrim, North Ireland, United Kingdom, BT36 4PP
      • Antrim, North Ireland, United Kingdom, BT37 9QN
      • Antrim, North Ireland, United Kingdom, BT41 3AE
      • Tyrone, North Ireland, United Kingdom, BT80 8BG
    • Northamptonshire
      • Wellingborough, Northamptonshire, United Kingdom, NN8 4RW
    • Oxfordshire
      • Chipping Norton, Oxfordshire, United Kingdom, OX75FA
    • SOuth Glamorgan
      • Barry, SOuth Glamorgan, United Kingdom, CF63 4HP
    • Sheffield
      • Eccles, Sheffield, United Kingdom, S35 9XQ
    • Somerset
      • Bath, Somerset, United Kingdom, BA1 2SR
    • South Yorkshire
      • Doncaster, South Yorkshire, United Kingdom, DN1 2ET
      • Sheffield, South Yorkshire, United Kingdom, S7 2DW
    • Stratchclyde
      • Chapelhall, Stratchclyde, United Kingdom, ML6 8SR
      • Glasgow, Stratchclyde, United Kingdom, G45 9AW
      • Hamilton, Stratchclyde, United Kingdom, ML3 ODR
      • Johnstone, Stratchclyde, United Kingdom, PA5 8EY
      • Motherwell, Stratchclyde, United Kingdom, ML1 3JX
    • Suffolk
      • Bury Saint Edmonds, Suffolk, United Kingdom, IP30 9QU
      • Bury St. Edmunds, Suffolk, United Kingdom, IP31 2HD
      • Bury St. Edmunds, Suffolk, United Kingdom, IP32 7EW
      • Hadleigh, Suffolk, United Kingdom, IP7 5DN
      • Stowmarket, Suffolk, United Kingdom, IP14 1NL
    • Surrey
      • Addlestone, Surrey, United Kingdom, KT15 2BH
      • East Horsley, Surrey, United Kingdom, KT24 6QT
      • Worcester Park, Surrey, United Kingdom, KT4 7BX
    • Tyne And Wear
      • Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE15 6TQ
    • Warwickshire
      • Coventry, Warwickshire, United Kingdom, CV6 4DD
      • Coventry, Warwickshire, United Kingdom, CV7 8LA
      • Rugby, Warwickshire, United Kingdom, CV21 3SP
    • West Midlands
      • Coventry, West Midlands, United Kingdom, CV9 1EU
    • West Sussex
      • Brighton, West Sussex, United Kingdom, BN2 1ES
      • Crawley, West Sussex, United Kingdom, RH10 1LL
      • Crawley, West Sussex, United Kingdom, RH10 7DX
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS10 3NB
      • Leeds, West Yorkshire, United Kingdom, LS118BS
      • Leeds, West Yorkshire, United Kingdom, LS15 9JH
      • Leeds, West Yorkshire, United Kingdom, LS25 1AN
      • Leeds, West Yorkshire, United Kingdom, LS25 1HB
      • Leeds, West Yorkshire, United Kingdom, LS25 7AB
      • Leeds, West Yorkshire, United Kingdom, LS26 8SZ
      • Leeds, West Yorkshire, United Kingdom, LS9 9EF
    • Wiltshire
      • Bradford-on-Avon, Wiltshire, United Kingdom, BA15 1DQ
      • Chippenham, Wiltshire, United Kingdom, SN15 2SB
      • Chippenham, Wiltshire, United Kingdom, SN14 6GT
      • Corsham, Wiltshire, United Kingdom, SN3 9DL
      • Trowbridge, Wiltshire, United Kingdom, BA14 9AR
      • Westbury, Wiltshire, United Kingdom, BA13 3FQ
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 39294
      • Graysville, Alabama, United States, 35073
      • Pell City, Alabama, United States, 35125
    • Arizona
      • Phoenix, Arizona, United States, 85051
      • Scottsdale, Arizona, United States, 85260
      • Tucson, Arizona, United States, 85712
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913-4457
    • California
      • Fremont, California, United States, 94536-3702
      • Huntington Park, California, United States, 90255
      • Los Angeles, California, United States, 90025
      • Rancho Cucamonga, California, United States, 91730
      • Rolling Hills Estates, California, United States, 90274
      • Santa Ana, California, United States, 92704
        • Helping Hands Clinical Trials
    • Delaware
      • Newark, Delaware, United States, 19702
    • Florida
      • Boynton Beach, Florida, United States, 33426
        • Medical Research Trust
      • Gainesville, Florida, United States, 32601
      • Hialeah, Florida, United States, 33016
      • Hollywood, Florida, United States, 33021
        • Medical Research Centers of South Florida, Inc.
      • Hollywood, Florida, United States, 33021
        • Office of Dr.Larry Levinson, DO
      • Kissimmee, Florida, United States, 34741
      • Largo, Florida, United States, 33770
      • Marianna, Florida, United States, 32446-2120
      • Panama City, Florida, United States, 32401
      • Quincy, Florida, United States, 32351
        • Tallahassee Memorial Family
      • Tampa, Florida, United States, 33614
    • Georgia
      • Atlanta, Georgia, United States, 30318
    • Illinois
      • Chicago, Illinois, United States, 60628
      • Chicago, Illinois, United States, 60631-1958
      • Lockport, Illinois, United States, 60491
      • Vernon Hills, Illinois, United States, 60061
    • Indiana
      • Evansville, Indiana, United States, 47713
      • Fort Wayne, Indiana, United States, 46804
    • Kentucky
      • Lebanon, Kentucky, United States, 40033
    • Maryland
      • Prince Frederick, Maryland, United States, 20678
    • Michigan
      • Bridgman, Michigan, United States, 49106
      • Cadillac, Michigan, United States, 49601
      • Interlochen, Michigan, United States, 49643-9264
      • Troy, Michigan, United States, 48085
    • Mississippi
      • Port Gibson, Mississippi, United States, 39150
    • Missouri
      • Florissant, Missouri, United States, 63031
    • Nebraska
      • Broken Bow, Nebraska, United States, 68822
      • Omaha, Nebraska, United States, 68114
      • Omaha, Nebraska, United States, 68116-2004
    • New Jersey
      • Belvidere, New Jersey, United States, 07823
      • Cherry Hill, New Jersey, United States, 08084
      • Clifton, New Jersey, United States, 07013
      • Hainesport, New Jersey, United States, 08036
      • Jersey City, New Jersey, United States, 07306
      • Lawrenceville, New Jersey, United States, 08648
      • Linden, New Jersey, United States, 07036
      • Perth Amboy, New Jersey, United States, 08861
        • PharmaTrials, Inc.
      • Stratford, New Jersey, United States, 08084
    • North Carolina
      • Burlington, North Carolina, United States, 27215
      • Columbus, North Carolina, United States, 28722
      • Greensboro, North Carolina, United States, 27401
      • Raleigh, North Carolina, United States, 27609
    • Ohio
      • Carlisle, Ohio, United States, 45005-3320
      • Marion, Ohio, United States, 43302
      • Montgomery, Ohio, United States, 45242
      • Perrysburg, Ohio, United States, 43551
    • Pennsylvania
      • Doylestown, Pennsylvania, United States, 18901
      • Duncansville, Pennsylvania, United States, 16635
      • Sellersville, Pennsylvania, United States, 18960
    • South Carolina
      • Taylors, South Carolina, United States, 29687
    • Texas
      • Daingerfield, Texas, United States, 75638
      • McKinney, Texas, United States, 75069
      • Rockwall, Texas, United States, 75032
      • San Antonio, Texas, United States, 78205-1116
      • San Marcos, Texas, United States, 78666
      • Stephenville, Texas, United States, 76401
      • Sugar Land, Texas, United States, 77478
    • Virginia
      • Honaker, Virginia, United States, 24260
      • Richlands, Virginia, United States, 24641-2067
        • Merit Medical Group, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males aged 55 years and above with 2 to 4 risk factors. Male Risk Factors:

    • Elevated cholesterol (Tchol>200 mg/dL or LDL>130 mg/dL; as measured at screening) irrespective of current treatment
    • Current smoking: defined as any cigarette smoking in the past 12 months
    • Low HDL cholesterol (HDL<40 mg/dL; as measured at screening)
    • Elevated blood pressure (SBP>140 mmHg; as measured at screening)
    • Currently on any medication to treat high blood pressure
    • Positive family history of early CHD (a first-degree relative [father, mother, brother, sister, son, daughter] suffered a heart attack [myocardial infarction] before the age of 60 years)

  • Females aged 60 and above with 3 or more risk factors. Female Risk Factors:

    • Elevated cholesterol (Tchol>240 mg/dL or LDL>160 mg/dL; as measured at screening) irrespective of current treatment
    • Current smoking: defined as any cigarette smoking in the past 12 months
    • Low HDL cholesterol (HDL<40 mg/dL; as measured at screening)
    • Elevated blood pressure (SBP>140 mmHg; as measured at screening)
    • Currently on any medication to treat high blood pressure
    • Positive family history of early CHD (a first-degree relative [father, mother, brother, sister, son, daughter] suffered a heart attack [myocardial infarction] before the age of 60 years)
  • An understanding and willingness to comply with trial procedures and has given written informed consent to participate in the trial

Exclusion Criteria:

  • History of a documented vascular event, such as MI, stroke, coronary artery angioplasty or stenting, coronary artery bypass graft, relevant arrhythmias, or congestive heart failure or vascular intervention
  • Patients who are at higher than moderate risk on the basis of their diabetes status, other factors known to the investigator, or the currently used national risk score
  • Known contraindications to the study drug, e.g. hypersensitivity to acetylsalicylic acid
  • Recent (in the past year) history of gastrointestinal or genitourinary bleeding or other bleeding disorders
  • Active diagnosed and documented reflux esophagitis
  • Patients presenting with any medical condition, or psychiatric or substance abuse disorder, that, in the opinion of the investigator, is likely to affect the patient's ability to complete the study or precludes the patient's participation in the study
  • Lactating women or women of childbearing potential
  • Severe liver disease or damage based on the clinical judgment of the investigator
  • Severe renal disease or damage based on the clinical judgement of the investigator
  • A definite indication for acetylsalicylic acid therapy, other antiplatelet drug, or anticoagulant in the opinion of the physician
  • A history of asthma induced by administration of salicylates or substances with a similar action, notably NSAIDS
  • Chronic, frequent (> 5 days/month) use of NSAIDs (including aspirin, or aspirin containing products), COX-2 inhibitors or metamizole
  • Current participation in any other trials involving investigational products within 30 days prior to the Screening Visit
  • Current use of an anticoagulant medication
  • Sitting systolic blood pressure greater than 170 mmHg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Acetylsalicylic acid (Aspirin, BAYE4465)
Participants received 1 tablet of enteric-coated acetylsalicylic acid [100 milligram (mg)] orally once daily.
Drug: Aspirin (Acetylsalicylic acid, BAYE4465)
100mg enteric coated Aspirin, taken daily
PLACEBO_COMPARATOR: Placebo
Participants received 1 tablets of matching placebo orally once daily.
Drug: Placebo
Placebo, taken daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to the First Occurrence of the Composite Outcome of MI (Myocardial Infarction), Stroke, Cardiovascular Death, UA (Unstable Angina) or TIA (Transient Ischemic Attack)
Time Frame: Until follow-up (approximate 6 years)
The primary efficacy endpoint was a composite outcome consisting of the first occurrence of confirmed MI, stroke, cardiovascular death, UA, TIA. The time to event was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.
Until follow-up (approximate 6 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to the First Occurrence of the Composite Outcome of Cardiovascular Death, MI, or Stroke (Ischemic, Hemorrhagic, or Unknown)
Time Frame: Until follow-up (approximate 6 years)
The time to Composite outcome consisting of the first occurrence of cardiovascular death, MI, or stroke (ischemic, hemorrhagic, or unknown) was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.
Until follow-up (approximate 6 years)
Time to the First Occurrence of the Individual Components of the Primary: Non-fatal MI, Total MI, Non-fatal Stroke, Total Stroke, Cardiovascular Death, UA and TIA
Time Frame: Until follow-up (approximately 6 years)
The time to event was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.
Until follow-up (approximately 6 years)
Time to All-cause Mortality, the First Occurrence of All Cancers Excluding Non-melanoma Skin Cancer (NMSC) and the First Occurrence of Colon Cancer
Time Frame: Until follow-up (approximately 6 years)
The time to event was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.
Until follow-up (approximately 6 years)
Incidence of All-cause Mortality, All Cancers Excluding Non-melanoma Skin Cancer and Colon Cancer
Time Frame: Until follow-up (approximately 6 years)
Until follow-up (approximately 6 years)
Incidence of Confirmed MI, Stroke, Cardiovascular Death, UA, and TIA Separately
Time Frame: Until follow-up (approximately 6 years)
The percentages of subjects with the efficacy endpoints of confirmed MI, stroke, cardiovascular death, UA and TIA are reported separately. *all other CV death without fatal MI and fatal stroke
Until follow-up (approximately 6 years)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With Adjudicated GI Bleeding by Severity
Time Frame: Until follow-up (approximate 6 years)
Until follow-up (approximate 6 years)
Incidence of Composite Outcomes and Non-fatal MI
Time Frame: Until follow-up (approximate 6 years)
Until follow-up (approximate 6 years)
Incidence of Composite Outcomes and Individual Outcomes in Per-protocol Population
Time Frame: Until follow-up (approximate 6 years)
*all other CV death without fatal MI and fatal stroke.
Until follow-up (approximate 6 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 5, 2007

Primary Completion (ACTUAL)

November 15, 2016

Study Completion (ACTUAL)

November 15, 2016

Study Registration Dates

First Submitted

July 12, 2007

First Submitted That Met QC Criteria

July 12, 2007

First Posted (ESTIMATE)

July 13, 2007

Study Record Updates

Last Update Posted (ACTUAL)

October 26, 2018

Last Update Submitted That Met QC Criteria

September 26, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12198
  • 2006-003622-29 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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