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Completed

NCT Number: NCT00372216

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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Universitaetsklinikum Innsbruck, Innsbruck, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clopidogrel (Iscover/Plavix)

Drug

Pre-hospital loading-dose of 600 mg Clopidogrel as early as possible

Other names: Iscover 75 mg filmtablets, Plavix 75 mg filmtablets

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Stiftung Institut fuer Herzinfarktforschung

Other

Collaborators

  • Bristol-Myers Squibb
  • Sanofi

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2010
First posted
Sep 6, 2006
Registry last updated
Nov 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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