Clinical trial NCT00372216: CIPAMI-Study: Clopidogrel Administered Prehospital to Improve Primary PCI in Patients With Acute Myocardial Infarction
Official title: CIPAMI-Study: Clopidogrel Administered Prehospital to Improve Primary PCI in Patients With Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myocardial Infarction
Keywords: myocardial infarction
Clopidogrel
primary PCI
TIMI-flow
STEMI within 6 hrs.
Lead sponsor: Stiftung Institut fuer Herzinfarktforschung
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
name: Sanofi
First posted: 2006-09-06
Enrollment: 337
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: TIMI 2/3 patency of the infarct-related artery immediately prior to PCI
timeFrame: Assessment at primary PCI, asap after inclusion of the subject
Secondary outcomes:
measure: TIMI 3 patency before PCI
timeFrame: Assessment before primary PCI, asap after inclusion of the subject
measure: TIMI 3 patency after PCI
timeFrame: Assessment at primary PCI, asap after inclusion of the subject
measure: ST resolution immediately before angiography and 60-90 minutes after PCI
timeFrame: Assessment immediately before angiography until 90 minutes after PCI
measure: Death, re-MI, urgent revascularisation until 48 hours and until hospital discharge
timeFrame: Starting with inclusion of the subject until day 7
measure: Stroke (hemorrhagic, non-hemorrhagic)
timeFrame: Starting with inclusion of the subject until day 7
measure: Severe bleeding complications according to the TIMI classification
timeFrame: Starting with inclusion of the subject until day 7
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Universitaetsklinikum Innsbruck
city: Wien
country: Austria
facility: Hanusch-Krankenhaus
city: Wien
country: Austria
facility: Wilhelminenspital
city: Mannheim
country: Germany
facility: Universitaetsklinikum Mannheim
state: Baden-Wuerttemberg
city: Wittstock
country: Germany
facility: KMG-Kliniken AG / Klinikum Wittstock
state: Brandenburg
city: Bad Nauheim
country: Germany
facility: Kerckhoff Klinik
state: Hessen
city: Darmstadt
country: Germany
facility: Klinikum Darmstadt
state: Hessen
city: Frankfurt
country: Germany
facility: Klinikum der Johann-Wolfgang-Goethe Universitaet
state: Hessen
city: Giessen
country: Germany
facility: Universitaetsklinikum Giessen
state: Hessen
city: Heppenheim
country: Germany
facility: Kreiskrankenhaus Bergstrasse
state: Hessen
city: Limburg
country: Germany
facility: St. Vincenz-Krankenhaus
state: Hessen
city: Rostock
country: Germany
facility: Universitaetsklinikum Rostock
state: Mecklenburg-Vorpommern
city: Celle
country: Germany
facility: Allgemeines Krankenhaus
state: Niedersachsen
city: Holzminden
country: Germany
facility: Evangelisches Krankenhaus
state: Niedersachsen
city: Lüneburg
country: Germany
facility: Städtisches Klinikum
state: Niedersachsen
city: Leverkusen
country: Germany
facility: Klinikum Leverkusen
state: Nordrhein-Westfalen
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen, Med. Klinik B
state: Rheinland-Pfalz
city: Saarbruecken
country: Germany
facility: Klinikum Saarbruecken
state: Saarland
city: Leipzig
country: Germany
facility: Universitaet Leipzig - Herzzentrum
state: Sachsen
city: Berlin
country: Germany
facility: Sana Klinikum Lichtenberg / Oskar-Ziethen-Krankenhaus
city: Berlin
country: Germany
facility: Universitaetsklinikum Benjamin Franklin
city: Berlin
country: Germany
facility: Vivantes Klinikum Neukoelln
city: Berlin
country: Germany
facility: Maria Heimsuchung / Caritas-Klinik Pankow
city: Berlin
country: Germany
facility: DRK-Kliniken Westend
city: Brandenburg
country: Germany
facility: Staedtisches Klinikum
Study officials:
affiliation: Klinikum der Stadt Ludwigshafen, Med. Klinik B, Ludwigshafen Germany
name: Uwe Zeymer, MD
role: PRINCIPAL_INVESTIGATOR
References: