CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 15,991 enrolled
Drug / intervention
Ticagrelor +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01813435
NCT01813435Phase 3Completed

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

ECRI bv·interventional·Posted Mar 19, 2013·Updated Mar 15, 2022

In Brief

A Phase 3 clinical trial evaluating Ticagrelor, Acetylsalicylic Acid, and 1 other intervention for Coronary Artery Disease (CAD). Completed, enrolled 15,991 participants across 130 sites in 18 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Austria, Belgium, Brazil, Bulgaria, Canada, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Singapore, Spain, Switzerland, United Kingdom

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 19, 2013
Enrollment StartJul 1, 2013
Primary CompletionNov 9, 2015
Study CompletionApr 26, 2018
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 13.3 years ago

Interventions

Ticagrelordrug

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.

Acetylsalicylic Aciddrug

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

Clopidogreldrug

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