Clopidogrel Versus Adenosin in Non Urgent Percutaneous Coronary Intervention (PCI) (RACE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by University of Roma La Sapienza.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT00751491
First received: September 11, 2008
Last updated: May 5, 2009
Last verified: May 2009
  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

Resource links provided by NLM:


Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • 20% [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00751491

Locations
Italy
Policlinico Umberto I Recruiting
Rome, Italy, 00161
Contact: GENNARO SARDELLA, MD    +390649979035    rino.sardella@uniroma1.it   
Principal Investigator: GENNARO SARDELLA, MD         
Sponsors and Collaborators
University of Roma La Sapienza
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
  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, Stable
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 August 21, 2014