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

NCT ID: NCT00751491

Last Updated: 2009-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-09-30

Brief Summary

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.

Conditions

Stable Angina; Percutaneous Coronary Intervention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

III

Group Type: ACTIVE_COMPARATOR

Clopidogrel

Intervention Type: DRUG

Clopidogrel 300/600 mg

A

Group Type: ACTIVE_COMPARATOR

Adenosin

Intervention Type: DRUG

Intracoronary Adenosin 50 microg;

placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

no intervention

Interventions

Adenosin

Intracoronary Adenosin 50 microg;

Intervention Type: DRUG

placebo

no intervention

Intervention Type: OTHER

Clopidogrel

Clopidogrel 300/600 mg

Intervention Type: DRUG

Other Intervention Names

PERCUTANEOUS CORONARY ANGIOGRAPHY

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

POLICLINICO UMBERTO I-SAPIENZA UNIVERSITY OF ROME

Principal Investigators

GENNARO SARDELLA, MD

Role: PRINCIPAL_INVESTIGATOR

DEPT.CARDIOLOGY-POLICLINICO UMBERTO I-SAPIENZA UNIVERSITY OF ROME

MASSIMO MANCONE, MD

Role: STUDY_DIRECTOR

DEPT.CARDIOLOGY-POLICLINICO UMBERTO I-SAPIENZA UNIVERSITY OF ROME

Locations

Policlinico Umberto I

Rome, , Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

GENNARO SARDELLA, MD

Role: primary

rino.sardella@uniroma1.it

+390649979035

Other Identifiers

SARD55

Identifier Type: -

Identifier Source: org_study_id