Prospective placebo controlled trial: Detection of coronary microembolization by Doppler ultrasound in patients with stable angina pectoris during percutaneous coronary interventions under an adjunctive antithrombotic therapy with abciximab.

INTERVENTION: Trade Name: ReoPro Product Name: ReoPro Pharmaceutical Form: Intravenous infusion INN or Proposed INN: ABCIXIMAB CAS Number: 143653536 Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 36,4‐ Pharmaceutical form of the placebo: Intravenous infusion Route of administration of the placebo: Intravenous use CONDITION: Up to 60 patients with stable angina pectoris and planned PCI at the University Clinic of Jena are randomly assigned to the glycoprotein IIb/IIIa receptor antagonist abciximab or placebo. Randomisation takes place after the diagnostic procedure with knowledge of the coronary anatomy. Patients are planned to undergo balloon dilatation with or without implantation of a bare metal stent for a single vessel stenosis. All will undergo periprocedural Doppler analysis. ; MedDRA version: 12.1 Level: LLT Classification code 10065608 Term: Percutaneous coronary intervention PRIMARY OUTCOME: Main Objective: Firstly, we investigate whether in patients with stable angina pectoris receiving a stent the incidence of microembolism is lower in patients who are treated with the glycoprotein IIb/IIIa receptor antagonist abciximab compared to patients who are treated with placebo (testing for superiority). Primary end point(s): Total number of HITS (in the time window specified below) in patients where a stent is deployed. The measurement of HITS for each patient is divided into 2 periods: (1) predilation and (2) stent deployment. Trigger points for the collection periods are balloon deflations during resulting appearance of the Doppler flow curves. HITS are counted within 60 seconds immediately after balloon deflations. Only bare stents will be used in this study.; Postprocedural CFVR and cardiac biomarkers are monitored for 36 hours after PCI in both groups. Secondary Objective: Secondly, we want to know whether the incidence of microembolism is directly related to changes in CFVR or elevation of cardiac biomarkers after PCI. INCLUSION CRITERIA: ‐ stable angina pectoris ‐ age between 18 and 80 years ‐ written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range