Trials

COMBINE

The COMBINE (OCT–FFR) trial is a prospective, multi-centre trial investigating the natural history of DM patients with ≥1 angiographically intermediate target lesion in three subgroups of patients; patients with FFR negative lesions without TCFA (group A) and patients with FFR negative lesions with TCFA (group B) as detected by OCT and to compare these two groups with each other, as well as to a third group with FFR-positive, PCI-treated intermediate lesions (group C).

The trial is designed to enrol 500 patients in The Netherlands, Luxembourg, Germany, Spain, Italy Switzerland and Belgium.

ASAF

The ASAF trial investigates the treatment of atrial fibrillation in patients with high sympathetic activity by pulmonary vein isolation in combination with renal denervation or pulmonary vein isolation only.

The physician-initiated, prospective, multicenter, randomized trial is currently enrolling 138 patients in centers in The Netherlands and Spain.

Early BAMI

The Early BAMI trial evaluated the beneficial effects of early administration of 5 mg intravenous Metoprolol or placebo before reperfusion in the ambulance or emergency room in patients with ST elevation myocardial infarction.

The physician-initiated, prospective, multicenter, randomized, double-blind, placebo controlled trial has now completed enrolment and follow up till two years of all 684 patients in 14 centers in The Netherlands and Spain.

On-TIME 2

The On TIME 2 trial investigated the effect of early up-front treatment with a high bolus dosage of tirofiban compared with no treatment in open label phase or placebo in double blind phase in addition to background treatment, on the extent of residual ST segment deviation 1 hour after Primary Coronary Angioplasty for acute myocardial infarction.

In total 414 patients were enrolled in the open label phase and 1398 patients in the double blind phase. The trial was conducted in Germany, Belgium and The Netherlands.