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

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Clopidogrel (Iscover/Plavix)
Sponsored by
Stiftung Institut fuer Herzinfarktforschung
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring myocardial infarction, Clopidogrel, primary PCI, TIMI-flow, STEMI within 6 hrs.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Universitaetsklinikum Innsbruck
  • Hanusch-Krankenhaus
  • Wilhelminenspital
  • Universitaetsklinikum Mannheim
  • KMG-Kliniken AG / Klinikum Wittstock
  • Kerckhoff Klinik
  • Klinikum Darmstadt
  • Klinikum der Johann-Wolfgang-Goethe Universitaet
  • Universitaetsklinikum Giessen
  • Kreiskrankenhaus Bergstrasse
  • St. Vincenz-Krankenhaus
  • Universitaetsklinikum Rostock
  • Allgemeines Krankenhaus
  • Evangelisches Krankenhaus
  • Städtisches Klinikum
  • Klinikum Leverkusen
  • Klinikum der Stadt Ludwigshafen, Med. Klinik B
  • Klinikum Saarbruecken
  • Universitaet Leipzig - Herzzentrum
  • Sana Klinikum Lichtenberg / Oskar-Ziethen-Krankenhaus
  • Universitaetsklinikum Benjamin Franklin
  • Vivantes Klinikum Neukoelln
  • Maria Heimsuchung / Caritas-Klinik Pankow
  • DRK-Kliniken Westend
  • Staedtisches Klinikum

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

1

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

TIMI 3 patency before PCI
TIMI 3 patency after PCI
ST resolution immediately before angiography and 60-90 minutes after PCI
Death, re-MI, urgent revascularisation until 48 hours and until hospital discharge
Stroke (hemorrhagic, non-hemorrhagic)
Severe bleeding complications according to the TIMI classification

Full Information

First Posted
September 4, 2006
Last Updated
November 18, 2010
Sponsor
Stiftung Institut fuer Herzinfarktforschung
Collaborators
Bristol-Myers Squibb, Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00372216
Brief Title
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

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Stiftung Institut fuer Herzinfarktforschung
Collaborators
Bristol-Myers Squibb, Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
myocardial infarction, Clopidogrel, primary PCI, TIMI-flow, STEMI within 6 hrs.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
337 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Pre-hospital loading dose of 600 mg Clopidogrel as early as possible (in addition to standard infarction therapy)
Arm Title
2
Arm Type
No Intervention
Arm Description
Standard infarction therapy (without study-specific additions, no Clopidogrel before angiography)
Intervention Type
Drug
Intervention Name(s)
Clopidogrel (Iscover/Plavix)
Other Intervention Name(s)
Iscover 75 mg filmtablets, Plavix 75 mg filmtablets
Intervention Description
Pre-hospital loading-dose of 600 mg Clopidogrel as early as possible
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
TIMI 3 patency before PCI
Time Frame
Assessment before primary PCI, asap after inclusion of the subject
Title
TIMI 3 patency after PCI
Time Frame
Assessment at primary PCI, asap after inclusion of the subject
Title
ST resolution immediately before angiography and 60-90 minutes after PCI
Time Frame
Assessment immediately before angiography until 90 minutes after PCI
Title
Death, re-MI, urgent revascularisation until 48 hours and until hospital discharge
Time Frame
Starting with inclusion of the subject until day 7
Title
Stroke (hemorrhagic, non-hemorrhagic)
Time Frame
Starting with inclusion of the subject until day 7
Title
Severe bleeding complications according to the TIMI classification
Time Frame
Starting with inclusion of the subject until day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uwe Zeymer, MD
Organizational Affiliation
Klinikum der Stadt Ludwigshafen, Med. Klinik B, Ludwigshafen Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitaetsklinikum Innsbruck
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
Facility Name
Hanusch-Krankenhaus
City
Wien
ZIP/Postal Code
A-1140
Country
Austria
Facility Name
Wilhelminenspital
City
Wien
ZIP/Postal Code
A-1171
Country
Austria
Facility Name
Universitaetsklinikum Mannheim
City
Mannheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
68167
Country
Germany
Facility Name
KMG-Kliniken AG / Klinikum Wittstock
City
Wittstock
State/Province
Brandenburg
ZIP/Postal Code
16909
Country
Germany
Facility Name
Kerckhoff Klinik
City
Bad Nauheim
State/Province
Hessen
ZIP/Postal Code
61231
Country
Germany
Facility Name
Klinikum Darmstadt
City
Darmstadt
State/Province
Hessen
ZIP/Postal Code
64283
Country
Germany
Facility Name
Klinikum der Johann-Wolfgang-Goethe Universitaet
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitaetsklinikum Giessen
City
Giessen
State/Province
Hessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Kreiskrankenhaus Bergstrasse
City
Heppenheim
State/Province
Hessen
ZIP/Postal Code
64646
Country
Germany
Facility Name
St. Vincenz-Krankenhaus
City
Limburg
State/Province
Hessen
ZIP/Postal Code
65549
Country
Germany
Facility Name
Universitaetsklinikum Rostock
City
Rostock
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
18057
Country
Germany
Facility Name
Allgemeines Krankenhaus
City
Celle
State/Province
Niedersachsen
ZIP/Postal Code
29223
Country
Germany
Facility Name
Evangelisches Krankenhaus
City
Holzminden
State/Province
Niedersachsen
ZIP/Postal Code
37603
Country
Germany
Facility Name
Städtisches Klinikum
City
Lüneburg
State/Province
Niedersachsen
ZIP/Postal Code
21339
Country
Germany
Facility Name
Klinikum Leverkusen
City
Leverkusen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
51375
Country
Germany
Facility Name
Klinikum der Stadt Ludwigshafen, Med. Klinik B
City
Ludwigshafen
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67063
Country
Germany
Facility Name
Klinikum Saarbruecken
City
Saarbruecken
State/Province
Saarland
ZIP/Postal Code
66119
Country
Germany
Facility Name
Universitaet Leipzig - Herzzentrum
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04289
Country
Germany
Facility Name
Sana Klinikum Lichtenberg / Oskar-Ziethen-Krankenhaus
City
Berlin
ZIP/Postal Code
10365
Country
Germany
Facility Name
Universitaetsklinikum Benjamin Franklin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Vivantes Klinikum Neukoelln
City
Berlin
ZIP/Postal Code
12351
Country
Germany
Facility Name
Maria Heimsuchung / Caritas-Klinik Pankow
City
Berlin
ZIP/Postal Code
13187
Country
Germany
Facility Name
DRK-Kliniken Westend
City
Berlin
ZIP/Postal Code
14050
Country
Germany
Facility Name
Staedtisches Klinikum
City
Brandenburg
ZIP/Postal Code
14770
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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