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

NCT00372216 | Completed Phase 3 DMC

• 1 other identifier: CIPAMI
• Study Type: interventional
• Target: 337
• Locations: 2 countries
• Sites: 25

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.

Conditions

Myocardial Infarction

Keywords

myocardial infarction; Clopidogrel; primary PCI; TIMI-flow; STEMI within 6 hrs.

Outcome Measures

Primary Outcomes (1)

• TIMI 2/3 patency of the infarct-related artery immediately prior to PCI

  Assessment at primary PCI, asap after inclusion of the subject

Secondary Outcomes (6)

• TIMI 3 patency before PCI

  Assessment before primary PCI, asap after inclusion of the subject

• TIMI 3 patency after PCI

  Assessment at primary PCI, asap after inclusion of the subject

• ST resolution immediately before angiography and 60-90 minutes after PCI

  Assessment immediately before angiography until 90 minutes after PCI

• Death, re-MI, urgent revascularisation until 48 hours and until hospital discharge

  Starting with inclusion of the subject until day 7

• Stroke (hemorrhagic, non-hemorrhagic)

  Starting with inclusion of the subject until day 7

Study Arms (2)

1

ACTIVE COMPARATOR

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

Drug: Clopidogrel (Iscover/Plavix)

2

NO INTERVENTION

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

Interventions

Clopidogrel (Iscover/Plavix) DRUG

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

Also known as: Iscover 75 mg filmtablets, Plavix 75 mg filmtablets

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stiftung Institut fuer Herzinfarktforschung: lead
• Bristol-Myers Squibb: collaborator
• Sanofi: collaborator

Study Sites (25)

Universitaetsklinikum Innsbruck

Innsbruck, A-6020, Austria

Location

Hanusch-Krankenhaus

Vienna, A-1140, Austria

Location

Wilhelminenspital

Vienna, A-1171, Austria

Location

Universitaetsklinikum Mannheim

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Staedtisches Klinikum

Brandenburg, Brandenburg, 14770, Germany

Location

KMG-Kliniken AG / Klinikum Wittstock

Wittstock, Brandenburg, 16909, Germany

Location

Kerckhoff Klinik

Bad Nauheim, Hesse, 61231, Germany

Location

Klinikum Darmstadt

Darmstadt, Hesse, 64283, Germany

Location

Klinikum der Johann-Wolfgang-Goethe Universitaet

Frankfurt am Main, Hesse, 60590, Germany

Location

Universitaetsklinikum Giessen

Giessen, Hesse, 35392, Germany

Location

Kreiskrankenhaus Bergstrasse

Heppenheim an der Bergstrasse, Hesse, 64646, Germany

Location

St. Vincenz-Krankenhaus

Limburg an der Lahn, Hesse, 65549, Germany

Location

Allgemeines Krankenhaus

Celle, Lower Saxony, 29223, Germany

Location

Evangelisches Krankenhaus

Holzminden, Lower Saxony, 37603, Germany

Location

Städtisches Klinikum

Lüneburg, Lower Saxony, 21339, Germany

Location

Universitaetsklinikum Rostock

Rostock, Mecklenburg-Vorpommern, 18057, Germany

Location

Klinikum Leverkusen

Leverkusen, North Rhine-Westphalia, 51375, Germany

Location

Klinikum der Stadt Ludwigshafen, Med. Klinik B

Ludwigshafen am Rhein, Rhineland-Palatinate, 67063, Germany

Location

Klinikum Saarbruecken

Saarbrücken, Saarland, 66119, Germany

Location

Universitaet Leipzig - Herzzentrum

Leipzig, Saxony, 04289, Germany

Location

Sana Klinikum Lichtenberg / Oskar-Ziethen-Krankenhaus

Berlin, State of Berlin, 10365, Germany

Location

Universitaetsklinikum Benjamin Franklin

Berlin, State of Berlin, 12200, Germany

Location

Vivantes Klinikum Neukoelln

Berlin, State of Berlin, 12351, Germany

Location

Maria Heimsuchung / Caritas-Klinik Pankow

Berlin, State of Berlin, 13187, Germany

Location

DRK-Kliniken Westend

Berlin, State of Berlin, 14050, Germany

Location

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Uwe Zeymer, MD

  Klinikum der Stadt Ludwigshafen, Med. Klinik B, Ludwigshafen Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 4, 2006
• First Posted: September 6, 2006
• Study Start: October 1, 2006
• Primary Completion: October 1, 2009
• Study Completion: January 1, 2010
• Last Updated: November 19, 2010

Record last verified: 2010-11

Locations

DE (22); AU (3)