GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation

Summary

After a stent procedure, it is common practice to prescribe anti-platelet medication to prevent the blood from clotting. The main objective of this study is to determine if there is a better medication strategy to prevent blood from clotting and at the same time minimising the number of complications.

There are two medication strategies:

* Study group: Dual anti-platelet therapy (ticagrelor combined with aspirin) for 1 month, and then ticagrelor alone for another 23 months OR
* Control group: Standard treatment, being dual anti-platelet therapy (ticagrelor or clopidogrel combined with aspirin) for 12 months, and then aspirin alone indefinitely

Conditions

• Coronary Artery Disease (CAD)

Interventions

DRUG

Ticagrelor

Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.

DRUG

Acetylsalicylic Acid

Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy

DRUG

Clopidogrel

Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy. Stable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy

Sponsors & Collaborators

• Biosensors International

  collaborator OTHER

• AstraZeneca

  collaborator INDUSTRY

• The Medicines Company

  collaborator INDUSTRY

• ECRI bv

  lead INDUSTRY

Principal Investigators

• Ernest Spitzer, MD · European Cardiovascular Research Institute

• Stephan Windecker, Prof. MD · Inselspital, University Hospital Bern, Switzerland

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-07-01

Primary Completion

2015-11-09

Completion

2018-04-26

Countries

• Australia
• Austria
• Belgium
• Brazil
• Bulgaria
• Canada
• Denmark
• France
• Germany
• Hungary
• Italy
• Netherlands
• Poland
• Portugal
• Singapore
• Spain
• Switzerland
• United Kingdom

Study Locations