Trials

TCW

The TCW trial aims to investigate whether FFR-guided PCI and TAVI strategy for treatment of MVD and AS will be non-inferior to CABG and SAVR for a composite primary endpoint of all-cause mortality, stroke, myocardial infarction, coronary or valve re-intervention and life-threatening or disabling bleeding at one year.

The trial is a prospective, randomized, controlled, open label, multicenter, international, non-inferiority trial designed to enrol 328 patients in up to 20 centers in Europe (The Netherlands, Germany, Denmark, Hungary, Spain, Greece, Austria and Portugal).

COLOR

COLOR stands for: COMPLEX LARGE-BORE RADIAL PCI TRIAL Introduction The COLOR trial aims to investigate whether ..

CIPA

The purpose of the CIPA Trial is to compare the efficacy and safety of complex fractionated atrial electrocardiograms (CFAEs) guided ablation to pulmonary vein isolation (PVI) based ablation in patients with persistent atrial fibrillation (AF).

The CIPA trial is an international (The Netherlands, France and Japan), multicenter, prospective, randomized, unblinded, clinical trial designed to enrol 120 patients.

EU-CaRE RCT (e-Health)

The aim of EU-CaRE is to improve quality of life and independency of elderly coronary patients (≥ 65 years old). A network of leading European experts from seven countries (The Netherlands, Denmark, Italy, Spain, Switzerland, Germany, Belgium and France) and 8 institutes have started this project in order to compare, improve and tailor cardiac rehabilitation programmes for these patients (EU-CaRE trial). In addition, the e-technology will be tested in a randomized control study (EU-CaRE RCT trial).

The trial is designed to enrol 238 patients in total.

EU-CaRE

The aim of EU-CaRE trial is to improve quality of life and independency of elderly coronary patients (≥ 65 years old). A network of leading European experts from seven countries (The Netherlands, Denmark, Spain, Switzerland, Italy, Germany and France) and 8 institutes have started this project in order to compare, improve and tailor cardiac rehabilitation programmes for these patients (EU-CaRE trial).

The trial is designed to enrol 1760 patients.

REDUCE

The REDUCE trial is designed to evaluate the potential for shorter-term dual antiplatelet therapy (DAPT) in acute coronary syndrome (ACS) patients treated with the COMBO Dual Therapy Stent.

The physician-initiated, prospective, multicenter, randomized trial has now completed enrolment of all 1500 patients in 36 centers in Asia (Hong Kong, Singapore, Malaysia and Indonesia) and Europe (The Netherlands, Italy, Belgium, Germany, Poland and Hungary).

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.