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

Percutaneous Coronary Intervention Clinical Trial

— RACE  

Official title:

Randomized Comparison of Adenosin Intracoronary Infusion and Clopidogrel Pretreatment on Myonecrosis Occurence in Elective PCI

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00751491
• Other study ID #: SARD55
• Status: Unknown status
• Phase: Phase 3
• First received: September 11, 2008
• Last updated: May 5, 2009
• Start date: September 2008
• Est. completion date: September 2009

Study information

• Verified date: May 2009
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 60
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 ?ow

• 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

Related Conditions & MeSH terms

• Angina, Stable
• Percutaneous Coronary Intervention
• Stable Angina

Intervention

Drug:
• Adenosin
Intracoronary Adenosin 50 microg;

Other:
• placebo
no intervention

Drug:
• Clopidogrel
Clopidogrel 300/600 mg

Locations

Country	Name	City	State
Italy	Policlinico Umberto I	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	20%		12 months
Secondary	0%		12 months