Platelet Sub-study of the TWILIGHT Trial

Sponsor

Juan Badimon (Other)

Overall Status

Completed

CT.gov ID

NCT04001374

Collaborator

(none)

Enrollment

Location

32.1

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Myocardial Infarction	Drug: Ticagrelor Drug: ASA

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.

Study Design

Study Type:

Observational

Actual Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Platelet Sub-study of the TWILIGHT Trial

Actual Study Start Date :

Jun 28, 2015

Actual Primary Completion Date :

Feb 28, 2018

Actual Study Completion Date :

Feb 28, 2018

Arms and Interventions

Arm	Intervention/Treatment
Ticagrelor Ticagrelor 90mg tablet bid for 12 months	Drug: Ticagrelor 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	Drug: Ticagrelor 90mg tablet bid for 12 months Drug: ASA enteric coated aspirin 81mg-100mg daily p.o. for 12 months

Arm

Intervention/Treatment

Ticagrelor

Ticagrelor 90mg tablet bid for 12 months

Drug: Ticagrelor

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

Drug: Ticagrelor

90mg tablet bid for 12 months

Drug: ASA

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

Outcome Measures

Primary Outcome Measures

Thrombus size (Badimon Chamber) [1-6 months after randomization]
Thrombus area measured 1-6 months after randomization

Secondary Outcome Measures

Platelet aggregation [1-6 months after randomization]
Platelet aggregation assessed using Multiplate Analyzer 1-6 months after randomization

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

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.