이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Hip Replacement Surgery (ADVANCE-3)

2014년 4월 14일 업데이트: Bristol-Myers Squibb

A Phase 3 Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Hip Replacement Surgery (The Advance-3 Study Apixaban Dosed Orally Versus Anticoagulation With Injectable Enoxaparin to Prevent Venous Thromboembolism)

The purpose of this study is to learn whether apixaban can prevent the blood clots in the leg (deep vein thrombosis) and lung (pulmonary embolism) that sometimes occur after hip replacement surgery and to learn how apixaban compares with enoxaparin in preventing these clots. The safety of apixaban will also be studied

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

5407

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 노르웨이
      • Gjettum, 노르웨이, 1346
        • Local Institution
      • Kongsvinger, 노르웨이, 2212
        • Local Institution
      • Lillehammer, 노르웨이, 2629
        • Local Institution
      • Tonsberg, 노르웨이, 3116
        • Local Institution
      • Tynset, 노르웨이, 2500
        • Local Institution
  • 덴마크
      • Amager, 덴마크, 2300
        • Local Institution
      • Frederiksberg, 덴마크, 2000
        • Local Institution
      • Herlev, 덴마크, 2730
        • Local Institution
      • Horsholm, 덴마크, 2970
        • Local Institution
      • Hvidovre, 덴마크, 2650
        • Local Institution
      • Kobenhavn Nv, 덴마크, 2400
        • Local Institution
      • Silkeborg, 덴마크, 8600
        • Local Institution
  • 독일
      • Frankfurt, 독일, 60528
        • Local Institution
      • Frankfurt / Main, 독일, 65929
        • Local Institution
      • Rheinfelden, 독일, 79618
        • Local Institution
  • 러시아 연방
      • Chelyabinsk, 러시아 연방, 454021
        • Local Institution
      • Kazan, 러시아 연방, 420029
        • Local Institution
      • Moscow, 러시아 연방, 115522
        • Local Institution
      • Moscow, 러시아 연방, 111539
        • Local Institution
      • Moscow, 러시아 연방, 117292
        • Local Institution
      • Moscow, 러시아 연방, 119415
        • Local Institution
      • Saint Petersburg, 러시아 연방, 199106
        • Local Institution
      • Saint Petersburg, 러시아 연방, 193312
        • Local Institution
      • Saint Petersburg, 러시아 연방, 194354
        • Local Institution
      • Saint Petersburg, 러시아 연방, 195427
        • Local Institution
      • Saint Petersburg, 러시아 연방, 196247
        • Local Institution
      • Samara, 러시아 연방, 443095
        • Local Institution
      • St.Petersburg, 러시아 연방, 192242
        • Local Institution
      • Yaroslavl, 러시아 연방, 150003
        • Local Institution
  • 루마니아
      • Bucharest, 루마니아, 021659
        • Local Institution
      • Cluj Napoca, 루마니아, 400132
        • Local Institution
  • 멕시코
      • Aguascalientes, 멕시코, 20010
        • Local Institution
      • Chihuahua, 멕시코, 31020
        • Local Institution
    • Baja California
      • Tijuana, Baja California, 멕시코, 22010
        • Local Institution
    • Distrito Federal
      • Mexico City, Distrito Federal, 멕시코, 06726
        • Local Institution
      • Mexico City, Distrito Federal, 멕시코, 07760
        • Local Institution
    • Jalisco
      • Guadalajara, Jalisco, 멕시코, 45235
        • Local Institution
    • Nuevo Leon
      • Monterrey, Nuevo Leon, 멕시코, 64460
        • Local Institution
    • Tamaulipas
      • Cd. Madero, Tamaulipas, 멕시코, 89240
        • Local Institution
  • 미국
    • Alabama
      • Birmingham, Alabama, 미국, 35209
        • West Alabama Research, Llc
      • Birmingham, Alabama, 미국, 35209
        • Capstone Clinical Trials, Inc
    • Arkansas
      • Little Rock, Arkansas, 미국, 72205
        • Martin Bowen Hefley Orthopedics
      • Little Rock, Arkansas, 미국, 72205
        • Orthoarkansas, P.A.
    • California
      • Sacramento, California, 미국, 95817
        • UC Davis Medical Center
    • Colorado
      • Aurora, Colorado, 미국, 80012
        • Colorado Orthopedic Consultants, PC
      • Denver, Colorado, 미국, 80230
        • Advanced Orthopedic And Sports Medicine Specilists
      • Denver, Colorado, 미국, 80230
        • Denver-Vail Orthopedics, P.C.
    • Florida
      • Brandon, Florida, 미국, 33511
        • PAB Clinical Research
      • Clearwater, Florida, 미국, 33756
        • Research Alliance, Inc.
      • Ft. Lauderdale, Florida, 미국, 33316
        • Shrock Orthopedic Research
      • Tamarac, Florida, 미국, 33321
        • Phoenix Clinical Research, LLC
    • Georgia
      • Decatur, Georgia, 미국, 30033
        • Atlanta Knee And Sports Medicine
    • Idaho
      • Boise, Idaho, 미국, 83702
        • Americana Orthopedics
      • Meridian, Idaho, 미국, 83642
        • Bosie Orthopedic Clinic
    • Pennsylvania
      • Altoona, Pennsylvania, 미국, 16602
        • University Orthopedic Center
    • Texas
      • Lubbock, Texas, 미국, 79410
        • Gill Orthopedic Center
      • Lubbock, Texas, 미국, 79410
        • Robert R. King, Md
      • San Antonio, Texas, 미국, 78217
        • Unlimited Research
  • 벨기에
      • Antwerp, 벨기에, 2020
        • Local Institution
      • Brasschaat, 벨기에, 2930
        • Local Institution
      • Genk, 벨기에, 3600
        • Local Institution
      • Hasselt, 벨기에, 3500
        • Local Institution
      • Leuven, 벨기에, 3000
        • Local Institution
  • 스웨덴
      • Gothenburg, 스웨덴, 416 85
        • Local Institution
      • Stockholm, 스웨덴, 182 88
        • Local Institution
  • 스페인
      • Badalona-Barcelone, 스페인, 08916
        • Local Institution
      • Barcelona, 스페인, 08035
        • Local Institution
      • Barcelona, 스페인, 08036
        • Local Institution
      • Barcelona, 스페인, 08006
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      • Barcelona, 스페인, 08024
        • Local Institution
  • 아르헨티나
    • Buenos Aires
      • Capital Federal, Buenos Aires, 아르헨티나, C1199ACK
        • Local Institution
      • Capital Federal, Buenos Aires, 아르헨티나, C1280AEB
        • Local Institution
      • Capital Federal, Buenos Aires, 아르헨티나, C1425AGP
        • Local Institution
      • Ciudad De Buenos Aires, Buenos Aires, 아르헨티나, C1426BOS
        • Local Institution
      • Coronel Suarez, Buenos Aires, 아르헨티나, B7540GHD
        • Local Institution
      • Monte Grande, Buenos Aires, 아르헨티나, B1842DID
        • Local Institution
  • 영국
    • Greater London
      • London, Greater London, 영국, SE5 9RS
        • Local Institution
    • Lancashire
      • Wigan, Lancashire, 영국, WN6 9EP
        • Local Institution
    • Surrey
      • Epsom, Surrey, 영국, KT18 7EG
        • Local Institution
  • 우크라이나
      • Cherkassy, 우크라이나, 18009
        • Local Institution
      • Chernivtsy, 우크라이나, 58013
        • Local Institution
      • Dnipropetrovsk, 우크라이나, 49005
        • Local Institution
      • Ivano-Frankivsk, 우크라이나, 76008
        • Local Institution
      • Kyiv, 우크라이나, 01601
        • Local Institution
      • Kyiv, 우크라이나, 04107
        • Local Institution
      • Sevastopol, 우크라이나, 99018
        • Local Institution
  • 이스라엘
      • Beer Sheva, 이스라엘, 84101
        • Local Institution
      • Haifa, 이스라엘, 31096
        • Local Institution
      • Holon, 이스라엘, 58100
        • Local Institution
      • Kfar-Saba, 이스라엘, 44281
        • Local Institution
      • Zerifin, 이스라엘, 70300
        • Local Institution
  • 인도
      • Bangalore, 인도, 560034
        • Local Institution
      • Mangalore, 인도, 575001
        • Local Institution
    • Gujarat
      • Ahmedabad, Gujarat, 인도, 380015
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    • Punjab
      • Ludhiana, Punjab, 인도, 141001
        • Local Institution
    • Uttar Prsdesh
      • Lucknow, Uttar Prsdesh, 인도, 226003
        • Local Institution
  • 중국
    • Beijing
      • Beijing, Beijing, 중국, 100853
        • Local Institution
      • Beijing, Beijing, 중국, 100035
        • Local Institution
    • Guangdong
      • Guangzhou, Guangdong, 중국, 510405
        • Local Institution
    • Shandong
      • Qingdao, Shandong, 중국, 266003
        • Local Institution
    • Shanghai
      • Shanghai, Shanghai, 중국, 200025
        • Local Institution
      • Shanghai, Shanghai, 중국, 200011
        • Local Institution
      • Shanghai, Shanghai, 중국, 200233
        • Local Institution
  • 캐나다
      • Quebec, 캐나다, G1L 3L5
        • Local Institution
    • Alberta
      • Edmonton, Alberta, 캐나다, T6G 2B7
        • Local Institution
    • Ontario
      • Ajax, Ontario, 캐나다, L1S 2J5
        • Local Institution
      • Cambridge, Ontario, 캐나다, N1R 7L7
        • Local Institution
      • Chatham, Ontario, 캐나다, N7L 4T1
        • Local Institution
      • Guelph, Ontario, 캐나다, N1E 6L9
        • Local Institution
      • Newmarket, Ontario, 캐나다, L3Y 5G8
        • Local Institution
      • Oshawa, Ontario, 캐나다, L1J 2J2
        • Local Institution
      • Sarnia, Ontario, 캐나다, N7T 6H3
        • Local Institution
      • Scarborough, Ontario, 캐나다, M1S 4T7
        • Local Institution
      • St. Catharines, Ontario, 캐나다, L2R 7P3
        • Local Institution
      • Stratford, Ontario, 캐나다, N5A 2N4
        • Local Institution
      • Waterloo, Ontario, 캐나다, N2J 1C4
        • Local Institution
      • Windsor, Ontario, 캐나다, N8W 1E6
        • Local Institution
    • Quebec
      • Montreal, Quebec, 캐나다, H3G 1A4
        • Local Institution
  • 폴란드
      • Gdansk, 폴란드, 80-803
        • Local Institution
      • Lodz, 폴란드, 91-002
        • Local Institution
      • Szczecin, 폴란드, 71-252
        • Local Institution
      • Warszawa, 폴란드, 03-242
        • Local Institution
      • Warszawa, 폴란드, 02-005
        • Local Institution
      • Wroclaw, 폴란드, 50-556
        • Local Institution
  • 프랑스
      • Nice, 프랑스, 06200
        • Local Institution
      • Paris, 프랑스, 75014
        • Local Institution
      • Paris, 프랑스, 75019
        • Local Institution
      • Paris, 프랑스, 75679
        • Local Institution
      • Saint Etienne, 프랑스, 42100
        • Local Institution
      • Saint-Saulve, 프랑스, 59880
        • Local Institution
  • 헝가리
      • Budapest, 헝가리, 1081
        • Local Institution
      • Kecskemet, 헝가리, 6000
        • Local Institution
      • Szeged, 헝가리, 6720
        • Local Institution
      • Szolnok, 헝가리, 5000
        • Local Institution
  • 호주
    • New South Wales
      • Camperdown, New South Wales, 호주, 2050
        • Local Institution
      • Kogarah, New South Wales, 호주, 2217
        • Local Institution
      • Lismore, New South Wales, 호주, 2480
        • Local Institution
    • Queensland
      • Southport, Queensland, 호주, 4215
        • Local Institution
    • South Australia
      • Bedford Park, South Australia, 호주, 5042
        • Local Institution
    • Victoria
      • Box Hill, Victoria, 호주, 3128
        • Local Institution
      • Malvern, Victoria, 호주, 3144
        • Local Institution
      • Windsor, Victoria, 호주, 3181
        • Local Institution
    • Western Australia
      • Perth, Western Australia, 호주, 6000
        • Local Institution

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Key Inclusion Criteria

  • Patients undergoing elective unilateral total hip replacement or a revision of at least 1 component of a total hip replacement.
  • Patients who were willing and able to undergo bilateral ascending contrast venography
  • Either sex, any race, 18 years and older

Key Exclusion Criteria

  • Known or suspected bleeding or coagulation disorder in the patient or his or her first-degree relative
  • Known or suspected history of heparin-induced thrombocytopenia
  • Known coagulopathy
  • Active bleeding or at high risk for bleeding
  • Brain, spinal, ophthalmologic, or major surgery or trauma within the past 90 days
  • Active hepatobiliary disease
  • Alcohol and/or substance abuse within the past year
  • Any condition for which surgery or administration of an anticoagulant is contraindicated
  • Two consecutive blood pressure readings within 15 to 30 minutes with supine systolic blood pressure >180 mm Hg or supine diastolic blood pressure >105 mm Hg
  • Clinically significant laboratory abnormalities at the enrollment visit:
  • Hemoglobin <10 g/dL
  • Platelet count <100,000/mm^3
  • Creatinine clearance <30 mL/min, as estimated by the method of Cockcroft and Gault
  • Alanine aminotransferase or aspartate aminotransferase >2*upper limit of normal or a total bilirubin ≥ 1.5*1 (unless an alternative causative factor such as Gilbert's syndrome was identified)
  • Need for ongoing treatment with a parenteral or oral anticoagulant (eg, subjects with mechanical valves, warfarin eligible atrial fibrillation)
  • Current use of dextrans or fibrinolytics
  • Treatment with medications affecting coagulation or platelet function

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Apixaban, 2.5 mg BID plus placebo
Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
의약품: Apixaban
Oral tablets, 2.5 mg, twice daily, 5weeks
다른 이름들:
  • BMS-562247
  • 엘리퀴스®
의약품: Enoxaparin-matching placebo
Administered as injection
실험적: Enoxaparin, 40 mg QD plus placebo
Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
의약품: Enoxaparin
Subcutaneous, 40 mg, once daily, 5 weeks
다른 이름들:
  • 러브녹스®
의약품: Apixaban-matching placebo
Administered as oral tablets

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Rate of Composite of Adjudicated Venous Thromboembolic Event (VTE)-Related (Pulmonary Embolism and Symptomatic and Asymptomatic Deep Vein Thrombosis[DVT]) and All-cause Death During the Intended Treatment Period
기간: Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose
Event rate=Number of events divided by the number of patients evaluated. A mandatory bilateral ascending contrast venogram was to be obtained on Day 35 (± 3). Patients with confirmed symptomatic DVT at any time, or asymptomatic DVT upon venography, were to receive treatment for DVT according to the investigator's standard of care. Signs and symptoms suggestive of VTE included, but were not limited to: 1) lower extremity DVT: erythema, warmth, pain, swelling, tenderness; and 2) PE: pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia. Intended Treatment Period started on day of randomization and, for patients who received treatment, ended at the later of 2 days after last dose of study drug or 38 days after the first dose (presurgery) of study drug. For randomized patients who did not receive study drug, the period ended 38 days after randomization.
Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose

2차 결과 측정

결과 측정
측정값 설명
기간
Rate of Composite of Adjudicated Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism, and Venous Thromboembolic Event-related Death With Onset During Intended Treatment Period
기간: Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose
Event rate=Number of events divided by the number of patients evaluated. Each patient was categorized as having no proximal DVT, having proximal DVT, being nonevaluable for proximal DVT, having no distal DVT, having distal DVT, or being nonevaluable for distal DVT. Adjudication criteria were: Normal=All deep veins were visualized, and there was no intraluminal filling defect (ILFD). ILFD=An area of reduced, or absent filling, at least partially surrounded with contrast medium in ≥ 2 projections or a lack of filling in a vessel in which there was a cut-off that had the configuration of a thrombus. Indeterminate=A lack of filling of a region of the deep vein system, proximal or distal, without the presence of an ILFD elsewhere in the same region. Not Done=A venography was not performed. Proximal DVT was found if any of the proximal veins had an ILFD. Pulmonary embolism was radiographically (angiography, V/Q scan, computed tomography) determined.
Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose
Rates of Adjudicated All-cause Death, VTE-related Death, Pulmonary Embolism (PE), Nonfatal PE, Deep Vein Thrombosis (DVT) (Symptomatic and Asymptomatic), Symptomatic and Asymptomatic Proximal and Distal DVT During the Intended Treatment Period
기간: Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose
VTE=venous thromboembolic event; VTE-related death=combination of fatal or nonfatal PE and symptomatic or asymptomatic DVT. Event rate=Number of events divided by the number of patients evaluated.
Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose
Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), Major or CRNM, and Any Bleeding During the Treatment Period
기간: First dose of study drug (presurgery) through 2 days after the last dose of study drug
Event rate=Number of events divided by the number of patients evaluated. Major bleeding event defined as a bleeding event that was 1) Acute clinically overt bleeding accompanied by at least 1 of the following: decrease in hemoglobin of ≥ 2 g/dL over a 24-hour period, transfusion of ≥2 units of packed red blood cells; bleeding that occurred in at least 1 of the following sites: intracranial, intra-spinal, intraocular, pericardial, an operated joint and requires reoperation or intervention, intramuscular with compartment syndrome, or retroperitoneal; 2) Fatal. CRNM was defined as acute clinically overt bleeding that did not satisfy the criteria for a major bleeding event and met at least 1 of the following: epistaxis, gastrointestinal bleed, hematuria, bruising/ecchymosis, or hemoptysis. Minor bleeding was defined as an acute clinically overt bleeding event that did not meet the criteria for major bleeding or a CRNM. Fatal bleeding event was defined as bleeding that was the primary
First dose of study drug (presurgery) through 2 days after the last dose of study drug
Number of Participants With Serious Adverse Events (SAEs), Bleeding Adverse Events (AEs), and Death as Outcome
기간: First dose of study drug (presurgery) through 30 days after the last dose of study drug
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. All suspected bleeding events were to be reported by the investigator as either an AE or SAE and adjudicated by the Independent Central Adjudication Committee (ICAC). Definitions of bleeding outcomes: Acute clinically overt bleeding =new onset, visible bleeding, or signs or symptoms suggestive of bleeding with confirmatory imaging techniques that could detect the presence of blood.
First dose of study drug (presurgery) through 30 days after the last dose of study drug
Number of Participants With a Bleeding-related Adverse Event During the Treatment Period
기간: First dose of study drug (presurgery) through 2 days after the last dose of study drug
All suspected bleeding events were to be reported by the investigator as either an adverse event or serious adverse event or and adjudicated by the Independent Central Adjudication Committee (ICAC). Definitions of bleeding outcomes: Acute clinically overt bleeding =new onset, visible bleeding, or signs or symptoms suggestive of bleeding with confirmatory imaging techniques that could detect the presence of blood. All acute clinically overt bleeding events were adjudicated by the ICAC as a major bleeding event or a clinically relevant nonmajor bleeding event; suspected minor bleeding events were not sent for adjudication.
First dose of study drug (presurgery) through 2 days after the last dose of study drug
Number of Participants With a Bleeding-related Adverse Events During the Treatment Period (Continued)
기간: First dose of study drug (presurgery) through 2 days after the last dose of study drug
All suspected bleeding events were to be reported by the investigator as either an adverse event or serious adverse event or and adjudicated by the Independent Central Adjudication Committee (ICAC). Definitions of bleeding outcomes: Acute clinically overt bleeding =new onset, visible bleeding, or signs or symptoms suggestive of bleeding with confirmatory imaging techniques that could detect the presence of blood. All acute clinically overt bleeding events were adjudicated by the ICAC as a major bleeding event or a clinically relevant nonmajor bleeding event; suspected minor bleeding events were not sent for adjudication.
First dose of study drug (presurgery) through 2 days after the last dose of study drug
Number of Participants With a Bleeding-related Adverse Event During the Treatment Period (Continued)
기간: First dose of study drug (presurgery) through 2 days after the last dose of study drug
All suspected bleeding events were to be reported by the investigator as either an adverse event or serious adverse event or and adjudicated by the Independent Central Adjudication Committee (ICAC). Definitions of bleeding outcomes: Acute clinically overt bleeding =new onset, visible bleeding, or signs or symptoms suggestive of bleeding with confirmatory imaging techniques that could detect the presence of blood. All acute clinically overt bleeding events were adjudicated by the ICAC as a major bleeding event or a clinically relevant nonmajor bleeding event; suspected minor bleeding events were not sent for adjudication.
First dose of study drug (presurgery) through 2 days after the last dose of study drug
Number of Participants With Neurologic Adverse Events With Onset During the Treatment Period
기간: First dose of study drug (presurgery) through 2 days after the last dose of study drug
Neurologic events were based on Medical Dictionary for Regulatory Activities search categories.For new or worsening events that were not related to the site of surgery, additional information was collected on a specific form. In addition, neurology consultation was to be obtained for these patients.
First dose of study drug (presurgery) through 2 days after the last dose of study drug
Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period
기간: First dose of study drug (presurgery) through 2 days after the last dose of study drug
preRx=predose; LLN=lower limit of normal; ULN=upper limit of normal. MA criteria: Hemoglobin: >2 g/dL decrease from preRx or value ≤ 8 g/dL; hematocrit (%): <0.75*preRx; platelet count (*10^9 cells/L): <100,000/mm^3; erythrocytes (*10^6 cells/μL): <0.75*preRx level; leukocytes (*10^3 cells/μL): < 0.75*LLN or >1.25*ULN, or if preRx LLN use < 0.8*preRx or >ULN if preRx >ULN use >1.2*preRx or <LLN; basophils (*10^3 cells/μL): >400/mm^3; eosinophils (*10^3 cells/μL): > 0.75*10^3 cells/μL; lymphocytes (*10^3 cells/μL): >0.75*10^3 cells/μL; monocytes (*10^3 cells/μL): >2000/mm^3; neutrophils (*10^3 cells/μL): <1.0;
First dose of study drug (presurgery) through 2 days after the last dose of study drug
Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period (Continued)
기간: First dose of study drug (presurgery) through 2 days after the last dose of study drug
preRx=predose; LLN=lower limit of normal; ULN=upper limit of normal. Alanine aminotransferase (ALT) (U/L): >3 *ULN: alkaline phosphatase (ALP) (U/L): >2* ULN; aspartate aminotransferase (ASP) (U/L): >3 *ULN; bilirubin, direct (mg/dL): >2*ULN; bilirubin, total (mg/dL): >2*ULN; BUN (mg/dL): >2*ULN; creatinine (mg/dL): >1.5*ULN; calcium (mg/dL): < 0.8*LLN or >1.2 *ULN, or if preRx <LLN use <0.75* preRx or >ULN if preRx >ULN use > 1.25*preRx or <LLN; chloride (mEq/L): <0.9*LLN or >1.1*ULN, or if preRx <LLN use <0.9*preRx or >ULN if preRx >ULN use >1.1* preRx or <LLN; bicarbonate (mEq/L): < 0.75* LLN or >1.25*ULN, or if preRx <LLN use <0.75*preRx or >ULN if preRx >ULN use >1.25*preRx or <LLN; potassium (mEq/L): < 0.9*LLN or >1.1*ULN, or if preRx <LLN use <0.9*preRx or >ULN if preRx >ULN use >1.1* preRx or < LLN; sodium (mEq/L): <0.95* LLN or >1.05×ULN, or if preRx <LLN use <0.95* predose or >ULN if preRx >ULN use >1.05 *preRx or < LLN.
First dose of study drug (presurgery) through 2 days after the last dose of study drug
Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period (Continued)
기간: First dose of study drug (presurgery) through 2 days after the last dose of study drug
preRx=predose; LLN=lower limit of normal; ULN=upper limit of normal. Glucose, fasting (mg/dL): <.8*LLN or >1.5*ULN, or if preRx <LLN use <.8*preRx or >ULN if preRx >ULN use >2*preRx or <LLN; protein, total (g/L): If missing preRx use ≥2, or if value ≥4 or preRx =0 or .5 use ≥2, or if preRx=1 use ≥3, or if preRx =2 or 3 use ≥4; creatine kinase (U/L): >5*ULN; uric acid (mg/dL): >.5* ULN, or if preRx >ULN use >2*preRx; blood, urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx =2 or 3 use ≥4; glucose, urine : If missing preRx use ≥2, or if value ≥4, or if preRx=0 or .5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; RBC, urine (hpf): If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx dose= 1 use ≥3, or if preRx=2 or 3 use ≥4; WBC, urine (h): If missing preRx use ≥2, or if value ≥4, or if preRx =0 or .5 use ≥2, or if preRx =1 use ≥3, or if preRx=2 or 3 use ≥4.
First dose of study drug (presurgery) through 2 days after the last dose of study drug
Number of Participants With Adverse Events Related to Elevations in Liver Function Test Results With Onset During the Treatment Period
기간: First dose of study drug (presurgery) through 30 days after the last dose of study drug
Treatment guidelines were provided for jaundice and elevated results of liver function tests.
First dose of study drug (presurgery) through 30 days after the last dose of study drug
Rates of Adjudicated Myocardial Infarction (MI)/Stroke, MI, Stroke, and Thrombocytopenia During the Intended Treatment Period
기간: Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose
Event rate=Number of events divided by the number of patients evaluated. All suspected events were reported by investigator. Acute MI=the presence of a clinical situation (eg, abnormal history, physical examination, new electrocardiogram changes) suggestive of an MI and at least 1 of the following: elevated creatine kinase (CK)-MB or troponin T or troponin I ≥2*upper limit of normal (ULN); if CK-MB or troponin values not available, total CK ≥2*ULN; or new significant (≥0.04 sec) Q waves in ≥2 contiguous leads. Stroke=a new focal neurologic deficit of sudden onset lasting at least 24 hours that was not due to a readily identifiable nonvascular cause. Adjudication classified each reported stroke as primary hemorrhagic, nonhemorrhagic, infarction with hemorrhagic conversion, or unknown type. Thrombocytopenia=after 3 days as drop in platelet count to <100,000/mm^3 for patients with a baseline value >150,000/mm^3 or a >50% decline, if the baseline value was ≤150,000/mm^3.
Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose

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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Bristol-Myers Squibb

간행물 및 유용한 링크

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일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2007년 3월 1일

기본 완료 (실제)

2009년 9월 1일

연구 완료 (실제)

2009년 9월 1일

연구 등록 날짜

최초 제출

2007년 1월 17일

QC 기준을 충족하는 최초 제출

2007년 1월 17일

처음 게시됨 (추정)

2007년 1월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2014년 5월 14일

QC 기준을 충족하는 마지막 업데이트 제출

2014년 4월 14일

마지막으로 확인됨

2014년 4월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CV185-035

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Apixaban에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Slovenia

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다