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Platelet Sub-study of the TWILIGHT Trial

NCT04001374 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2020-02-26

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Ticagrelor

90mg tablet bid for 12 months

DRUG

ASA

enteric coated aspirin 81mg-100mg daily p.o. for 12 months

Sponsors & Collaborators

  • Juan Badimon

    lead OTHER

Principal Investigators

  • Juan Badimon, PhD · Icahn School of Medicine at Mount Sinai

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-28
Primary Completion
2018-02-28
Completion
2018-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04001374 on ClinicalTrials.gov