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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00751491
Acronym
RACE
Enrollment
60
Registered
2008-09-12
Start date
2008-09-30
Completion date
2009-09-30
Last updated
2009-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Percutaneous Coronary Intervention, Stable Angina

Keywords

Stable angina, Percutaneous Coronary Intervention, Myonecrosis

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.

Interventions

DRUGAdenosin

Intracoronary Adenosin 50 microg;

OTHERplacebo

no intervention

DRUGClopidogrel

Clopidogrel 300/600 mg

Sponsors

University of Roma La Sapienza
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frame
20%12 months

Secondary

MeasureTime frame
0%12 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026