THE TRAPIDIL RESTENOSIS TRIAL (STARC STUDY) - BACKGROUND, METHODS ANDCLINICAL CHARACTERISTICS OF THE PATIENT POPULATION

Restenosis remains the principal drawback of percutaneous transluminal coronary angioplasty (PTCA) since 30-35% of patients still experience it 6 months after the intervention. Several studies have clearly demo nstrated that restenosis is a complex multifactorial process that invo lves smooth muscle cell (SMC) migration and proliferation in the intim al layer of the coronary artery. Among others, the platelet-derived gr owth factor (PDGF) seems to play an important role in this process. Th at is why researches have been made in finding and developing new agen ts able to inhibit PDGF. Trapidil (triazolopyrimidine) (T), is a poten t PDGF inhibitor that has been efficacious in preventing restenosis af ter balloon angioplasty in the experimental animal and after PTCA in a limited clinical trial. The Trapidil Restenosis Trial (STARC study) i s a double blind randomized trial of T 100 mg t.i.d. vs. Aspirin (ASA) 100 mg t.i.d. 360 patients have been enrolled from April 1990 until M ay 1992, excluding recent myocardial infarctions, thrombolysis, resten otic and venous graft lesions and 302 have terminated follow-up. This paper describes the clinical background, the protocol and baseline dat a of the patient population including data regarding initial stenosis and type of vessel treated.