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. - REOPRO HITs

• Conditions: p 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: 12.1Level: LLTClassification code 10065608Term: Percutaneous coronary intervention

• Registration Number: EUCTR2010-019688-12-DE
• Lead Sponsor: Friedrich-Schiller University Jena, Clinic for Internal Medicine I

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-22
• Last Update Posted: 11 February 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

Exclusion Criteria

- elevation of cardiac biomarkers before PCI
- left bundle branch block
- terminal renal insufficiency
- hypothyroidism
- skeletal muscle injury
- occluded target artery
- bifurcation lesion
- in-stent restenosis
- multivessel intervention
- occlusion of side branche(s)
- prolonged vasospasm
- contraindication for use of abciximab

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified