CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 9,006 enrolled
Drug / intervention
Aspirin +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/NCT02270242
NCT02270242Phase 4Completed

Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention

Icahn School of Medicine at Mount Sinai·interventional·Posted Oct 21, 2014·Updated Jan 13, 2021

In Brief

A Phase 4 clinical trial evaluating Aspirin, Placebo, and 1 other intervention for Cardiovascular Disease and Interventional Cardiology. Completed, enrolled 9,006 participants across 1 site.

Detailed Summary

The purpose of this study is to compare the use of ticagrelor alone versus ticagrelor and aspirin together. Both ticagrelor and aspirin stop platelets from sticking together and forming a blood clot that could block blood flow to the heart. This study will look to determine the effectiveness and safety of ticagrelor alone, compared to ticagrelor plus aspirin in reducing clinically relevant bleeding and in reducing ischemic adverse events among high-risk patients who have had a percutaneous intervention with at least one drug-eluting stent. A patient is considered high-risk if they meet certain clinical and/or anatomic criteria. Up to 9000 subjects will be enrolled at the time of their index PCI. Subjects meeting randomization eligibility criteria at 3 months post enrollment will be randomized to either ticagrelor plus aspirin or ticagrelor plus placebo for an additional 12 months. Follow-up clinic visits will be performed at 3 months, 9 months and 15 months post enrollment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsAstraZeneca

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 21, 2014
Enrollment StartJul 1, 2015
Primary CompletionJul 10, 2019
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 11.7 years ago

Interventions

Aspirindrug

Placebodrug

ticagrelordrug