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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00372216
Recruitment Status : Completed
First Posted : September 6, 2006
Last Update Posted : November 19, 2010
Bristol-Myers Squibb
Information provided by:
Stiftung Institut fuer Herzinfarktforschung

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: Clopidogrel (Iscover/Plavix) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 337 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CIPAMI-Study: Clopidogrel Administered Prehospital to Improve Primary PCI in Patients With Acute Myocardial Infarction
Study Start Date : October 2006
Actual Primary Completion Date : October 2009
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

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)

Primary Outcome Measures :
  1. 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 ]

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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00372216

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

Responsible Party: Prof. Dr. Jochen Senges, Stiftung Institut fuer Herzinfarktforschung Ludwigshafen Identifier: NCT00372216     History of Changes
Other Study ID Numbers: CIPAMI
First Posted: September 6, 2006    Key Record Dates
Last Update Posted: November 19, 2010
Last Verified: November 2010

Keywords provided by Stiftung Institut fuer Herzinfarktforschung:
myocardial infarction
primary PCI
STEMI within 6 hrs.

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors