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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.
 
ClinicalTrials.gov Identifier: NCT00372216
Recruitment Status : Completed
First Posted : September 6, 2006
Last Update Posted : November 19, 2010
Sponsor:
Collaborators:
Bristol-Myers Squibb
Sanofi
Information provided by:
Stiftung Institut fuer Herzinfarktforschung

Tracking Information
First Submitted Date  ICMJE September 4, 2006
First Posted Date  ICMJE September 6, 2006
Last Update Posted Date November 19, 2010
Study Start Date  ICMJE October 2006
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2008)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 4, 2006)
TIMI 2/3 patency of the infarct-related artery immediately prior to PCI
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2008)
  • TIMI 3 patency before PCI [ Time Frame: 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 ]
  • ST resolution immediately before angiography and 60-90 minutes after PCI [ Time Frame: 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 ]
  • Stroke (hemorrhagic, non-hemorrhagic) [ Time Frame: 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2006)
  • TIMI 3 patency before PCI
  • TIMI 3 patency after PCI
  • ST resolution immediately before angiography and 60-90 minutes after PCI
  • Death, re-MI, urgent revascularisation until 48 hours and until hospital discharge
  • Stroke (hemorrhagic, non-hemorrhagic)
  • Severe bleeding complications according to the TIMI classification
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CIPAMI-Study: Clopidogrel Administered Prehospital to Improve Primary PCI in Patients With Acute Myocardial Infarction
Official Title  ICMJE CIPAMI-Study: Clopidogrel Administered Prehospital to Improve Primary PCI in Patients With Acute Myocardial Infarction
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Myocardial Infarction
Intervention  ICMJE 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
Study Arms  ICMJE
  • Active Comparator: 1
    Pre-hospital loading dose of 600 mg Clopidogrel as early as possible (in addition to standard infarction therapy)
    Intervention: Drug: Clopidogrel (Iscover/Plavix)
  • No Intervention: 2
    Standard infarction therapy (without study-specific additions, no Clopidogrel before angiography)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 18, 2010)
337
Original Enrollment  ICMJE
 (submitted: September 4, 2006)
654
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00372216
Other Study ID Numbers  ICMJE CIPAMI
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Dr. Jochen Senges, Stiftung Institut fuer Herzinfarktforschung Ludwigshafen
Study Sponsor  ICMJE Stiftung Institut fuer Herzinfarktforschung
Collaborators  ICMJE
  • Bristol-Myers Squibb
  • Sanofi
Investigators  ICMJE
Principal Investigator: Uwe Zeymer, MD Klinikum der Stadt Ludwigshafen, Med. Klinik B, Ludwigshafen Germany
PRS Account Stiftung Institut fuer Herzinfarktforschung
Verification Date November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP