TWILIGHT Study The anti platelet therapy with both ticagrelor and aspirin for 3 months after coronary intervention followed by ticagrelor only for a year rather than both aspirin and ticagrelor is better in reducing the ischemic events in high risk patients.
- Conditions
- Health Condition 1: null- Patients with acute coronary syndrome and undergone PCI with one drug eluting stent
- Registration Number
- CTRI/2016/07/007090
- Lead Sponsor
- ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 610
Clinical Inclusion Criteria (MUST MEET AT LEAST ONE):
1. Adult patients >= 65 years of age
2. Female gender
3.Troponin positive acute coronary syndrome
4. Established vascular disease defined as previous MI, documented PAD or CAD/PAD revascularization
5. Diabetes mellitus treated with medications (oral hypoglycemic, subcutaneous injection of insulin)
6. 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):
7. Multivessel coronary artery disease
8.Target lesion requiring total stent length >30 mm
9.Thrombotic target lesion(s)
10.Bifurcation lesions with Medina X,1,1 classification requiring at least 2 stents
11. Left main (>=50%) or proximal LAD (>=70%) lesion
12. Calcified target lesion(s) requiring atherectomy
Exclusion Criteria:
1.Under 18 years of age
2.Contraindication to aspirin
3. Contraindication to ticagrelor
4. Planned surgery within 90 days
5. Planned coronary revascularization (surgical or percutaneous) within 90 days
6.Need for chronic oral anticoagulation
7.Prior stroke
8.Dialysis-dependent renal failure
9.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)
10.Salvage PCI or STEMI presentation.
11.Liver cirrhosis
12.Life expectancy < 1 year
13.Unable or unwilling to provide informed consent
14.Women of child bearing potential (as determined by hospital standard of care)
Fibrinolytic therapy within 24 hours of index PCI
15. Concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer
16.Platelet count < 100,000 mm3
17.Requiring ongoing treatment with aspirin >= 325 mg daily
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method