NCT04001374

Platelet Sub-study of the TWILIGHT Trial

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: Juan Badimon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

TWILIGHT study is a multicenter RCT comparing treatment with ticagrelor alone versus ticagrelor plus aspirin in high-risk patients after PCI. All patients will receive DAPT (ticagrelor plus aspirin) for the initial 3 months post-PCI and then be randomized to either Ticagrelor alone OR Ticagrelor plus Aspirin DAPT. To investigate the pharmacodynamic effects of the two treatments in this trial, a 'Platelet Sub-study' will be conducted only at the Mount Sinai Medical Center. The sub-study will recruit randomized patients from the TWILIGHT Trial at Mount Sinai and conduct specialized blood tests at randomization and one month thereafter. The aim of the Platelet Sub-study is to compare the antithrombotic effects of Ticagrelor alone versus Ticagrelor plus Aspirin using an ex vivo model of thrombosis (Badimon Chamber).

Detailed description

The present study will enroll a cohort of randomized patients from the TWILIGHT trial at the Mount Sinai Medical Center. These subjects will undergo blood sampling and measurement of thrombotic indices at the time of randomization and 1-6 months thereafter.

Conditions

• Coronary Artery Disease
• Myocardial Infarction

Interventions

Type	Name	Description
DRUG	Ticagrelor	90mg tablet bid for 12 months
DRUG	ASA	enteric coated aspirin 81mg-100mg daily p.o. for 12 months

Timeline

• Start date: 2015-06-28
• Primary completion: 2018-02-28
• Completion: 2018-02-28
• First posted: 2019-06-28
• Last updated: 2020-02-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study