Interventional Cardiology and Angiology

The influence of Treatment with the AT1-Receptor-Antagonist Candesartan cilexetil (Atacand) on the Prevention of In-Stent Restenosis in Patients with Coronary Artery Disease.
The Candesartan Cilexetil In-Stent Restenosis Prevention Trial (C A I R P)

• The CAIRP study is a double-blind randomized, placebo-controlled study (300 patients) that will assess the ability of Candesartan cilexetil to reduce the rate of restenosis after stent implantation and cardiac events at follow up of 6 months.
• The patients will enter an open run-in-phase of individual duration. During the run-in-phase normal blood pressure values should be achieved. Usual care medication represents a heterogeneous mix of therapies that may include calcium channel blocker (nifedipine-type), betablocker, ACE inhibitors, diuretics, nitrates, diet and behaviour modification.
• All patients are required to have normotensive blood pressure (< 160/90 mmHg, resting) under medication before randomisation. In case of hypertension, it is necessary to increase, in hypotensive patients to decrease drug dosage of usual care medication to maintain comparable blood pressure. The modification of dosage will be determined by the investigator.
• Randomisation: Visit 2 is the visit at which qualifying patients will be randomized. If blood pressure is < 160/90 mmHg, patients will be randomized to a treatment with either placebo or candesartan cilexetil and treatment will be initiated according to randomisation list.
• Primary objective
  • To compare the effect of a 6 months treatment with either 8-16 mg candesartan cilexetil or placebo on the restenosis rate after stent implantation in patients with coronary artery disease and nomalized blood pressure.
  • Primary efficacy variable: Change in mean coronary artery segment diameter after 6 months treatment as measured by quantitative coronary angiography.
• Secondary objectives
  • To compare the effects of a candesartan cilexetil vs. placebo treatment
    • on different parameters indicating ventricular function, exercise capacity
    • on major cardiac events (MACE-criteria)
    • on disturbance of renal function (serum creatinin, creatinin-clearance)
  • The tolerability of either treatment will be determined by registration of adverse events and routine laboratory tests.
  • Follow-up: Clinic visits will occur after 1 and 6 months. At all visits clinical events (history-taking), registration of adverse events, routine laboratory tests will be performed.
  • Initially and after 6 months of treatment the restenosis rate will be measured by quantitative coronary.