Myocardial InfarctionPhase 3NCT00372216
CIPAMI-Study: Clopidogrel Administered Prehospital to Improve Primary PCI in Patients With Acute Myocardial Infarction
A Phase 3 study testing Clopidogrel (Iscover/Plavix) in people with Myocardial Infarction, run by Stiftung Institut fuer Herzinfarktforschung at 25 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Clopidogrel (Iscover/Plavix)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 337 participants
- Where
- 25 sitesin 2 countries
- Study dates
- Oct 2006to Jan 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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 locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
Germany22 sites
Kerckhoff Klinik
Bad Nauheim, Hesse, 61231
Sana Klinikum Lichtenberg / Oskar-Ziethen-Krankenhaus
Berlin, State of Berlin, 10365
Universitaetsklinikum Benjamin Franklin
Berlin, State of Berlin, 12200
Vivantes Klinikum Neukoelln
Berlin, State of Berlin, 12351
Maria Heimsuchung / Caritas-Klinik Pankow
Berlin, State of Berlin, 13187
DRK-Kliniken Westend
Berlin, State of Berlin, 14050
Staedtisches Klinikum
Brandenburg an der Havel, Brandenburg, 14770
Allgemeines Krankenhaus
Celle, Lower Saxony, 29223
Klinikum Darmstadt
Darmstadt, Hesse, 64283
Klinikum der Johann-Wolfgang-Goethe Universitaet
Frankfurt am Main, Hesse, 60590
Universitaetsklinikum Giessen
Giessen, Hesse, 35392
Kreiskrankenhaus Bergstrasse
Heppenheim an der Bergstrasse, Hesse, 64646
Evangelisches Krankenhaus
Holzminden, Lower Saxony, 37603
Universitaet Leipzig - Herzzentrum
Leipzig, Saxony, 04289
Klinikum Leverkusen
Leverkusen, North Rhine-Westphalia, 51375
St. Vincenz-Krankenhaus
Limburg an der Lahn, Hesse, 65549
Klinikum der Stadt Ludwigshafen, Med. Klinik B
Ludwigshafen am Rhein, Rhineland-Palatinate, 67063
Städtisches Klinikum
Lüneburg, Lower Saxony, 21339
Universitaetsklinikum Mannheim
Mannheim, Baden-Wurttemberg, 68167
Universitaetsklinikum Rostock
Rostock, Mecklenburg-Vorpommern, 18057
Klinikum Saarbruecken
Saarbrücken, Saarland, 66119
KMG-Kliniken AG / Klinikum Wittstock
Wittstock, Brandenburg, 16909
Austria3 sites
Universitaetsklinikum Innsbruck
Innsbruck, A-6020
Hanusch-Krankenhaus
Vienna, A-1140
Wilhelminenspital
Vienna, A-1171
About this study
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
- Being tested
- Clopidogrel (Iscover/Plavix)
- Keywords
- myocardial infarction, Clopidogrel, primary PCI, TIMI-flow, STEMI within 6 hrs.
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clopidogrel (Iscover/Plavix)Drug
Also called Iscover 75 mg filmtablets, Plavix 75 mg filmtablets
Pre-hospital loading-dose of 600 mg Clopidogrel as early as possible
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Pre-hospital loading dose of 600 mg Clopidogrel as early as possible (in addition to standard infarction therapy) Receives: Drug: Clopidogrel (Iscover/Plavix) |
| 2 | No intervention | Standard infarction therapy (without study-specific additions, no Clopidogrel before angiography) |
What is being measured
The primary outcome is the main question the study is designed to answer.
TIMI 2/3 patency of the infarct-related artery immediately prior to PCI
Measured: Assessment at primary PCI, asap after inclusion of the subject
Secondary outcomes (6)
TIMI 3 patency before PCI
Measured: Assessment before primary PCI, asap after inclusion of the subject
TIMI 3 patency after PCI
Measured: Assessment at primary PCI, asap after inclusion of the subject
ST resolution immediately before angiography and 60-90 minutes after PCI
Measured: Assessment immediately before angiography until 90 minutes after PCI
Death, re-MI, urgent revascularisation until 48 hours and until hospital discharge
Measured: Starting with inclusion of the subject until day 7
Stroke (hemorrhagic, non-hemorrhagic)
Measured: Starting with inclusion of the subject until day 7
Severe bleeding complications according to the TIMI classification
Measured: Starting with inclusion of the subject until day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2006 (estimated)
- Study startOct 2006
- Primary completionOct 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stiftung Institut fuer Herzinfarktforschung
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, Sanofi
- Investigators
- Uwe Zeymer, MD, Principal investigator, Klinikum der Stadt Ludwigshafen, Med. Klinik B, Ludwigshafen Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00372216
- Sponsor's protocol ID
- CIPAMI
- Status last verified
- Nov 2010
- First submitted
- 4 Sep 2006
- Last updated
- 19 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CIPAMI-Study: Clopidogrel Administered Prehospital to Improve Primary PCI in Patients With Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00372216
- Acronym / sponsor ID
- CIPAMI
- Conditions
- Myocardial Infarction
- Keywords
- myocardial infarction, Clopidogrel, primary PCI, TIMI-flow, STEMI within 6 hrs.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- Stiftung Institut fuer HerzinfarktforschungUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, Sanofi
- Study start
- Oct 2006
- Primary completion
- Oct 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 6 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Clopidogrel (Iscover/Plavix)Pre-hospital loading dose of 600 mg Clopidogrel as early as possible (in addition to standard infarction therapy) |
| 2 | No intervention | –Standard infarction therapy (without study-specific additions, no Clopidogrel before angiography) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clopidogrel (Iscover/Plavix)Also: Iscover 75 mg filmtablets, Plavix 75 mg filmtabletsPre-hospital loading-dose of 600 mg Clopidogrel as early as possible | Drug | 1 |
Primary outcome
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
6 secondary outcomes
TIMI 3 patency before PCI
Time frame: Assessment before primary PCI, asap after inclusion of the subject
TIMI 3 patency after PCI
Time frame: Assessment at primary PCI, asap after inclusion of the subject
ST resolution immediately before angiography and 60-90 minutes after PCI
Time frame: Assessment immediately before angiography until 90 minutes after PCI
Death, re-MI, urgent revascularisation until 48 hours and until hospital discharge
Time frame: Starting with inclusion of the subject until day 7
Stroke (hemorrhagic, non-hemorrhagic)
Time frame: Starting with inclusion of the subject until day 7
Severe bleeding complications according to the TIMI classification
Time frame: Starting with inclusion of the subject until day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uwe Zeymer, MD principal investigator
Klinikum der Stadt Ludwigshafen, Med. Klinik B, Ludwigshafen Germany
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clopidogrel (Iscover/Plavix) in people with Myocardial Infarction, run by Stiftung Institut fuer Herzinfarktforschung at 25 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2010.