Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen

Summary

The study compares two lengths of medication therapy (a shortened versus a prolonged dual antiplatelet therapy) in order to prevent thrombus (blood cloth) formation after the successfully treatment for coronary heart disease with a drug covered stent (metallic tube).

This comparison will be done in patients who, compared to the average patient, are more likely to suffer from complications on antiplatelet therapy (bleeding). Both durations are within the current medical recommendations. The aim of this study is to help improve further standard antiplatelet duration guidelines.

Conditions

• High Bleeding Risk
• Coronary Artery Disease
• PCI

Interventions

DRUG

Aspirin

Dosing per current guidelines and local practice

DRUG

P2Y12 inhibitor

Dosing per current guidelines and local practice

Sponsors & Collaborators

• Cardialysis B.V.

  collaborator INDUSTRY

• European Cardiovascular Research Center

  collaborator NETWORK

• University of Bern

  collaborator OTHER

• Terumo Medical Corporation

  collaborator INDUSTRY

• ECRI bv

  lead INDUSTRY

Principal Investigators

• M. Valgimigli, Prof. · Cardiocentro Ticino Foundation, Lugano, Switzerland

• P. Smits, Dr. · Maasstad Ziekenhuis Rotterdam, The Netherlands

• E. Spitzer, Dr. · ECRI bv

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-04-04

Primary Completion

2021-04-30

Completion

2021-04-30

Countries

• Argentina
• Australia
• Austria
• Bahrain
• Bangladesh
• Belgium
• Bulgaria
• Czechia
• Denmark
• Estonia
• France
• Germany
• Hungary
• India
• Israel
• Italy
• Japan
• Netherlands
• North Macedonia
• Poland
• Saudi Arabia
• Serbia
• Singapore
• Slovenia
• South Korea
• Spain
• Sweden
• Switzerland
• United Kingdom
• Vietnam

Study Locations