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.

Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2016/07/007090

Enrollment

9000

Registered

2016-07-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patients with acute coronary syndrome and undergone PCI with one drug eluting stent

Interventions

Intervention1: Aspirin is the study drug and ticagrelor is a open label study drug.: There are two arms both will receive ticagrelor and one would receive Aspirin and the other the aspirin placebo,asp

Eligibility

Inclusion criteria

Inclusion criteria: 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) 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

Exclusion criteria: 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 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 17.Requiring ongoing treatment with aspirin >= 325 mg daily

Design outcomes

Primary

Measure	Time frame
The primary bleeding endpoint of the present study is the time to first occurrence of clinically relevant bleeding, defined as Bleeding Academic Research Consortium (BARC) Types 2, 3 or 5 bleeding. The primary ischemic endpoint of the present study is the time to first occurrence of confirmed all-cause death, non-fatal myocardial infarction, or stroke.Timepoint: 12 months	—

Secondary

Measure	Time frame
Ischemic episode [ Time Frame: 12 months ] [ Designated as safety issue: Yes ] the time to first occurrence of confirmed cardiovascular death, non-fatal myocardial infarction, ischemic stroke or ischemia-driven revascularizationTimepoint: 12 months	—

Countries

Brazil, Bulgaria, Canada, Denmark, Egypt, France, Hungary, India, Israel, Italy, New Zealand, Poland, South Africa, United Kingdom, United States of America

Contacts

Public ContactDr Upendra Kaul

Fortis Escort Heart Institute,Okhla,New delhi

upendra.kaul@fortishealthcare.com011268250014243

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026