Clopidogrel Versus Adenosin in Non Urgent Percutaneous Coronary Intervention (PCI) (RACE)
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Stable Angina Percutaneous Coronary Intervention |
Drug: Adenosin Other: placebo Drug: Clopidogrel |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Comparison of Adenosin Intracoronary Infusion and Clopidogrel Pretreatment on Myonecrosis Occurence in Elective PCI |
- 20% [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- 0% [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | September 2009 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: III |
Drug: Clopidogrel
Clopidogrel 300/600 mg
|
| Active Comparator: A |
Drug: Adenosin
Intracoronary Adenosin 50 microg;
Other Name: PERCUTANEOUS CORONARY ANGIOGRAPHY
|
| Placebo Comparator: placebo |
Other: placebo
no intervention
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Italy | |
| Policlinico Umberto I | Recruiting |
| Rome, Italy, 00161 | |
| Contact: GENNARO SARDELLA, MD +390649979035 rino.sardella@uniroma1.it | |
| Principal Investigator: GENNARO SARDELLA, MD | |
| 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 |
More Information
No publications provided
| Responsible Party: | GENNARO SARDELLA, POLICLINICO UMBERTO I-SAPIENZA UNIVERSITY OF ROME |
| ClinicalTrials.gov Identifier: | NCT00751491 History of Changes |
| Other Study ID Numbers: | SARD55 |
| Study First Received: | September 11, 2008 |
| Last Updated: | May 5, 2009 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by University of Roma La Sapienza:
|
Stable angina Percutaneous Coronary Intervention Myonecrosis |
Additional relevant MeSH terms:
|
Angina Pectoris Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Chest Pain Pain Signs and Symptoms Clopidogrel Platelet Aggregation Inhibitors |
Hematologic Agents Therapeutic Uses Pharmacologic Actions Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013