- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00751491
Clopidogrel Versus Adenosin in Non Urgent Percutaneous Coronary Intervention (PCI) (RACE)
May 5, 2009 updated by: University of Roma La Sapienza
Randomized Comparison of Adenosin Intracoronary Infusion and Clopidogrel Pretreatment on Myonecrosis Occurence in Elective PCI
Percutaneous coronary intervention (PCI) is associated with up to 30% incidence of myonecrosis, as reflected by elevation of cardiac enzymes in a successful procedure.
Apart from side-branch occlusion, intimal dissection and coronary spasm, a possible aetiology of myonecrosis after PCI might be distal embolization of atherogenic materials from plaque disruption causing obstruction of blood flow at capillary level resulting in micro-infarction.
Recent studies have suggested that pretreatment with adenosine in the cath lab and Clopidogrel and statins greater than 6 hours before may be associated with a reduction in infarct size after reperfusion therapy for acute myocardial infarction.
Whether pretreatment with adenosine decreases the incidence of myonecrosis in patients undergoing non-urgent PCI is not fully known.
The investigators propose that adenosine-induced hyperaemia can potentially ameliorate the deleterious effects of distal embolization associated with non-urgent PCI through dilatation of the microvasculature.
Mechanistically, this may reduce capillary obstruction by facilitating the throughput passage of embolized platelet thrombi out to the venous end of the coronary circulation, thereby reducing the incidence of post-PCI myonecrosis.
In this prospective, randomized, open-label study, the investigators evaluated the incidence of myonecrosis after non-urgent PCI with a treatment with intracoronary adenosine compared with pretreatment of loading dose of Clopidogrel 300/600 mg >/< 6 hours.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Rome, Italy, 00161
- Recruiting
- Policlinico Umberto I
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Baseline creatine-kinase (CK) and creatine-kinase-myocardial band (CK-MB) had to be within normal limits (a normal CK and CK-MB and elevated troponin allowed inclusion)
Exclusion Criteria:
- Occlusion resulting in Thrombolysis In Myocardial Infarction (TIMI) grade 0 antegrade flow
- Thrombus-laden lesions
- Significant left main coronary stenosis
- Left ventricular ejection fraction 30%
- Inability to give informed consent
- Bradycardia with heart rate below 50 b.p.m.
- Allergy to adenosine
- The occurrence of myo-cardial infarction within one week
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: placebo
|
no intervention
|
Active Comparator: A
|
Intracoronary Adenosin 50 microg;
Other Names:
|
Active Comparator: III
|
Clopidogrel 300/600 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
20%
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
0%
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: GENNARO SARDELLA, MD, DEPT.CARDIOLOGY-POLICLINICO UMBERTO I-SAPIENZA UNIVERSITY OF ROME
- Study Director: MASSIMO MANCONE, MD, DEPT.CARDIOLOGY-POLICLINICO UMBERTO I-SAPIENZA UNIVERSITY OF ROME
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Anticipated)
September 1, 2009
Study Completion (Anticipated)
September 1, 2009
Study Registration Dates
First Submitted
September 11, 2008
First Submitted That Met QC Criteria
September 11, 2008
First Posted (Estimate)
September 12, 2008
Study Record Updates
Last Update Posted (Estimate)
May 6, 2009
Last Update Submitted That Met QC Criteria
May 5, 2009
Last Verified
May 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Pain
- Neurologic Manifestations
- Chest Pain
- Angina Pectoris
- Angina, Stable
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Platelet Aggregation Inhibitors
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Clopidogrel
Other Study ID Numbers
- SARD55
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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