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

Institute for Heart Attack Research Foundation (IHF)

Status and phase: Completed; Phase 3

Conditions: Myocardial Infarction

Treatments: Drug: Clopidogrel (Iscover/Plavix)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00372216

CIPAMI

Details and patient eligibility

About

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.

Enrollment: 337 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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337 participants in 2 patient groups

1

Active Comparator group

Description:

Pre-hospital loading dose of 600 mg Clopidogrel as early as possible (in addition to standard infarction therapy)

Treatment:

Drug: Clopidogrel (Iscover/Plavix)

2

No Intervention group

Description:

Standard infarction therapy (without study-specific additions, no Clopidogrel before angiography)