CIPAMI-Study: Clopidogrel Administered Prehospital to Improve Primary PCI in Patients With Acute Myocardial Infarction

November 18, 2010 updated by: Stiftung Institut fuer Herzinfarktforschung

Acute myocardial infarction is generally caused by a thrombotic occlusion of coronary arteries. Primary aim of early therapy is a fast and complete reperfusion of the infarcted myocardium, which can be achieved by either thrombolytic therapy or primary PCI.

Primary PCI is facilitated if the flow in the target vessel is restored prior to the intervention. In addition the results of recent trials hint that clinical outcome is improved by a patent infarct-vessel before primary PCI. The CIPAMI-study analyses the effect of an early administration of Clopidogrel on the flow-rates in subjects who suffered an acute myocardial infarction. For this purpose they are divided into two groups, both receiving standard baseline treatment. The subjects of one group additionally receive 600mg of Clopidogrel, as early as possible, while the subjects in the second group receive standard therapy. In the second group Clopidogrel is not allowed before initial angiography.

In both groups the flow-rates before and after PCI are analysed and compared in order to evaluate the efficacy, feasibility, and safety of the administration of a high loading dose Clopidogrel in the very early phase of STEMI in the prehospital setting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

337

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

  • Austria
      • Innsbruck, Austria, A-6020
        • Universitaetsklinikum Innsbruck
      • Wien, Austria, A-1140
        • Hanusch-Krankenhaus
      • Wien, Austria, A-1171
        • Wilhelminenspital
  • Germany
      • Berlin, Germany, 12351
        • Vivantes Klinikum Neukoelln
      • Berlin, Germany, 14050
        • DRK-Kliniken Westend
      • Berlin, Germany, 10365
        • Sana Klinikum Lichtenberg / Oskar-Ziethen-Krankenhaus
      • Berlin, Germany, 12200
        • Universitaetsklinikum Benjamin Franklin
      • Berlin, Germany, 13187
        • Maria Heimsuchung / Caritas-Klinik Pankow
      • Brandenburg, Germany, 14770
        • Staedtisches Klinikum
    • Baden-Wuerttemberg
      • Mannheim, Baden-Wuerttemberg, Germany, 68167
        • Universitaetsklinikum Mannheim
    • Brandenburg
      • Wittstock, Brandenburg, Germany, 16909
        • KMG-Kliniken AG / Klinikum Wittstock
    • Hessen
      • Bad Nauheim, Hessen, Germany, 61231
        • Kerckhoff Klinik
      • Darmstadt, Hessen, Germany, 64283
        • Klinikum Darmstadt
      • Frankfurt, Hessen, Germany, 60590
        • Klinikum der Johann-Wolfgang-Goethe Universitaet
      • Giessen, Hessen, Germany, 35392
        • Universitaetsklinikum Giessen
      • Heppenheim, Hessen, Germany, 64646
        • Kreiskrankenhaus Bergstrasse
      • Limburg, Hessen, Germany, 65549
        • St. Vincenz-Krankenhaus
    • Mecklenburg-Vorpommern
      • Rostock, Mecklenburg-Vorpommern, Germany, 18057
        • Universitaetsklinikum Rostock
    • Niedersachsen
      • Celle, Niedersachsen, Germany, 29223
        • Allgemeines Krankenhaus
      • Holzminden, Niedersachsen, Germany, 37603
        • Evangelisches Krankenhaus
      • Lüneburg, Niedersachsen, Germany, 21339
        • Städtisches Klinikum
    • Nordrhein-Westfalen
      • Leverkusen, Nordrhein-Westfalen, Germany, 51375
        • Klinikum Leverkusen
    • Rheinland-Pfalz
      • Ludwigshafen, Rheinland-Pfalz, Germany, 67063
        • Klinikum der Stadt Ludwigshafen, Med. Klinik B
    • Saarland
      • Saarbruecken, Saarland, Germany, 66119
        • Klinikum Saarbruecken
    • Sachsen
      • Leipzig, Sachsen, Germany, 04289
        • Universitaet Leipzig - Herzzentrum

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Acute STEMI <= 6 hrs.
  • Planned percutaneous coronary intervention
  • Age >= 18 years
  • Ability to understand the natures, scope, and possible consequences of the study / legal capacity
  • Informed consent

Exclusion Criteria:

  • Thrombolytic therapy within 24 hours before randomization
  • Effective oral or intravenous anticoagulation (INR>2, or PTT>2xcontrol)
  • Known hemorrhagic diathesis
  • Stroke or TIA within 3 months
  • Evidence of an active gastrointestinal or urogenital bleeding
  • Major surgery (including CABG) within 6 weeks
  • Contraindication to Clopidogrel
  • Severe renal or hepatic insufficiency
  • Contraindication to coronary angiography
  • Planned administration of a GP IIb/IIIa-Inhibitor before angiography
  • Pregnant or nursing (lactating) women
  • Women with childbearing potential
  • Patients currently (within the last 10 days) treated with clopidogrel or ticlopidine
  • Participation in another clinical or device trial within the previous 30 days

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Pre-hospital loading dose of 600 mg Clopidogrel as early as possible (in addition to standard infarction therapy)
Drug: Clopidogrel (Iscover/Plavix)
Pre-hospital loading-dose of 600 mg Clopidogrel as early as possible
Other Names:
  • Iscover 75 mg filmtablets
  • Plavix 75 mg filmtablets
NO_INTERVENTION: 2
Standard infarction therapy (without study-specific additions, no Clopidogrel before angiography)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
TIMI 2/3 patency of the infarct-related artery immediately prior to PCI
Time Frame: Assessment at primary PCI, asap after inclusion of the subject
Assessment at primary PCI, asap after inclusion of the subject

Secondary Outcome Measures

Outcome Measure
Time Frame
TIMI 3 patency before PCI
Time Frame: Assessment before primary PCI, asap after inclusion of the subject
Assessment before primary PCI, asap after inclusion of the subject
TIMI 3 patency after PCI
Time Frame: Assessment at primary PCI, asap after inclusion of the subject
Assessment at primary PCI, asap after inclusion of the subject
ST resolution immediately before angiography and 60-90 minutes after PCI
Time Frame: Assessment immediately before angiography until 90 minutes after PCI
Assessment immediately before angiography until 90 minutes after PCI
Death, re-MI, urgent revascularisation until 48 hours and until hospital discharge
Time Frame: Starting with inclusion of the subject until day 7
Starting with inclusion of the subject until day 7
Stroke (hemorrhagic, non-hemorrhagic)
Time Frame: Starting with inclusion of the subject until day 7
Starting with inclusion of the subject until day 7
Severe bleeding complications according to the TIMI classification
Time Frame: Starting with inclusion of the subject until day 7
Starting with inclusion of the subject until day 7

Collaborators and Investigators

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

Sponsor

Stiftung Institut fuer Herzinfarktforschung

Collaborators

Bristol-Myers Squibb
Sanofi

Investigators

  • Principal Investigator: Uwe Zeymer, MD, Klinikum der Stadt Ludwigshafen, Med. Klinik B, Ludwigshafen Germany

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

October 1, 2006

Primary Completion (ACTUAL)

October 1, 2009

Study Completion (ACTUAL)

January 1, 2010

Study Registration Dates

First Submitted

September 4, 2006

First Submitted That Met QC Criteria

September 4, 2006

First Posted (ESTIMATE)

September 6, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

November 19, 2010

Last Update Submitted That Met QC Criteria

November 18, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIPAMI

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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