Platelet Sub-study of the TWILIGHT Trial

Completed

Conditions studied: Coronary Artery Disease, Myocardial Infarction

In brief

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).

Key facts

Study ID

NCT04001374

Run by

Juan Badimon

People needed

40

Starts

2015-06-28

Expected to finish

2018-02-28

Last updated by the study team

2020-02-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients enrolled in the TWILIGHT trial:
• Clinical Inclusion Criteria (must meet at least one):
• 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
• Angiographic Inclusion Criteria (must meet at least one):
• 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

You may not qualify if…

• 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.

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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