Platelet Sub-study of the TWILIGHT Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-28

Study Completion Date

2018-02-28

Brief Summary

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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).

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Detailed Description

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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

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Coronary Artery Disease Myocardial Infarction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ticagrelor

Ticagrelor 90mg tablet bid for 12 months

Ticagrelor

Intervention Type DRUG

90mg tablet bid for 12 months

Ticagrelor + ASA

Ticagrelor 90mg tablet bid for 12 months and enteric coated aspirin 81mg-100mg daily p.o. for 12 months

Ticagrelor

Intervention Type DRUG

90mg tablet bid for 12 months

ASA

Intervention Type DRUG

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

Interventions

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Ticagrelor

90mg tablet bid for 12 months

Intervention Type DRUG

ASA

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients enrolled in the TWILIGHT trial:

* Adult patients ≥ 65 years of age
* Troponin (+) acute coronary syndrome
* Female gender
* Established vascular disease defined as previous MI, documented PAD or CAD/PAD revascularization
* Diabetes mellitus treated with medications (oral hypoglycemic, subcutaneous injection of insulin)
* Chronic kidney disease defined as an estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73m2 or creatinine clearance (CrCl) \< 60 ml/min

* Multivessel coronary artery disease
* Target lesion requiring total stent length \>30 mm
* Thrombotic target lesion(s)
* Bifurcation lesions with Medina X,1,1 classification requiring at least 2 stents
* Left main (≥50%) or proximal LAD (≥70%) lesion
* Calcified target lesion(s) requiring atherectomy

Exclusion Criteria

Patients not eligible to participate in the TWILIGHT trial:

* Under 18 years of age
* Contraindication to aspirin
* Contraindication to ticagrelor
* Planned surgery within 90 days
* Planned coronary revascularization (surgical or percutaneous) within 90 days
* Need for chronic oral anticoagulation
* Prior stroke
* Dialysis-dependent renal failure
* Active bleeding or extreme-risk for major bleeding (e.g. active peptic ulcer disease, gastrointestinal pathology with a raised risk for bleeding, malignancies with a raised risk for bleeding)
* Emergent or salvage PCI or STEMI presentation.
* Liver cirrhosis
* Life expectancy \< 1 year
* Unable or unwilling to provide informed consent
* Women of child bearing potential (as determined by hospital standard of care)
* Fibrinolytic therapy within 24 hours of index PCI
* Concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer
* Platelet count \< 100,000 mm3
* Requiring ongoing treatment with aspirin \> 325 mg daily.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No