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

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 Type: Interventional

Study Design: Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Study Primary Completion Date: October 2009

Intervention(s) in this Clinical Trial

• Drug: Clopidogrel (Iscover/Plavix)
  • Pre-hospital loading-dose of 600 mg Clopidogrel as early as possible

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Pre-hospital loading dose of 600 mg Clopidogrel as early as possible (in addition to standard infarction therapy)
• No Intervention: 2
  • Standard infarction therapy (without study-specific additions, no Clopidogrel before angiography)

Primary 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
    Safety Issue?: No

Secondary Measures

• TIMI 3 patency before PCI
  • Time Frame: Assessment before primary PCI, asap after inclusion of the subject
    Safety Issue?: No
• TIMI 3 patency after PCI
  • Time Frame: Assessment at primary PCI, asap after inclusion of the subject
    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
    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
    Safety Issue?: Yes
• Stroke (hemorrhagic, non-hemorrhagic)
  • Time Frame: Starting with inclusion of the subject until day 7
    Safety Issue?: Yes
• Severe bleeding complications according to the TIMI classification
  • Time Frame: Starting with inclusion of the subject until day 7
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Stiftung Institut fuer Herzinfarktforschung

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on March 18, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00372216

Study ID Number: CIPAMI

ClinicalTrials.gov Identifier: NCT00372216

Health Authority: Germany: Federal Institute for Drugs and Medical Devices