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

This study has been completed.
Sponsor:
Collaborators:
Bristol-Myers Squibb
Sanofi
Information provided by:
Stiftung Institut fuer Herzinfarktforschung
ClinicalTrials.gov Identifier:
NCT00372216
First received: September 4, 2006
Last updated: November 18, 2010
Last verified: November 2010
  Purpose

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 Intervention Phase
Myocardial Infarction
Drug: Clopidogrel (Iscover/Plavix)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CIPAMI-Study: Clopidogrel Administered Prehospital to Improve Primary PCI in Patients With Acute Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Stiftung Institut fuer Herzinfarktforschung:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • TIMI 3 patency before PCI [ Time Frame: Assessment before primary PCI, asap after inclusion of the subject ] [ Designated as safety issue: No ]
  • TIMI 3 patency after PCI [ Time Frame: Assessment at primary PCI, asap after inclusion of the subject ] [ Designated as safety issue: No ]
  • ST resolution immediately before angiography and 60-90 minutes after PCI [ Time Frame: Assessment immediately before angiography until 90 minutes after PCI ] [ Designated as safety issue: No ]
  • Death, re-MI, urgent revascularisation until 48 hours and until hospital discharge [ Time Frame: Starting with inclusion of the subject until day 7 ] [ Designated as safety issue: Yes ]
  • Stroke (hemorrhagic, non-hemorrhagic) [ Time Frame: Starting with inclusion of the subject until day 7 ] [ Designated as safety issue: Yes ]
  • Severe bleeding complications according to the TIMI classification [ Time Frame: Starting with inclusion of the subject until day 7 ] [ Designated as safety issue: Yes ]

Enrollment: 337
Study Start Date: October 2006
Study Completion Date: January 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00372216

Locations
Austria
Universitaetsklinikum Innsbruck
Innsbruck, Austria, A-6020
Wilhelminenspital
Wien, Austria, A-1171
Hanusch-Krankenhaus
Wien, Austria, A-1140
Germany
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
Maria Heimsuchung / Caritas-Klinik Pankow
Berlin, Germany, 13187
DRK-Kliniken Westend
Berlin, Germany, 14050
Vivantes Klinikum Neukoelln
Berlin, Germany, 12351
Universitaetsklinikum Benjamin Franklin
Berlin, Germany, 12200
Staedtisches Klinikum
Brandenburg, Germany, 14770
Sponsors and Collaborators
Stiftung Institut fuer Herzinfarktforschung
Bristol-Myers Squibb
Sanofi
Investigators
Principal Investigator: Uwe Zeymer, MD Klinikum der Stadt Ludwigshafen, Med. Klinik B, Ludwigshafen Germany
  More Information

No publications provided

Responsible Party: Prof. Dr. Jochen Senges, Stiftung Institut fuer Herzinfarktforschung Ludwigshafen
ClinicalTrials.gov Identifier: NCT00372216     History of Changes
Other Study ID Numbers: CIPAMI
Study First Received: September 4, 2006
Last Updated: November 18, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases
Clopidogrel
Ticlopidine
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014