TWILIGHT StudyTicagrelor With Aspirin or Alone in High-Risk Patients After CoronaryInterventio

Phase 1

• Conditions: Bleeding among high-risk patients with percutanous coronary intervention with at least one drug-eluting stent; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]; MedDRA version: 21.1Level: PTClassification code 10065608Term: Percutaneous coronary interventionSystem Organ Class: 10042613 - Surgical and medical procedures

• Registration Number: EUCTR2014-005498-35-IT
• Lead Sponsor: INTERVENTIONAL CARDIOVASC. RESEARCH & CLINICAL TRIALS AT ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-05
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 9000

Inclusion Criteria

Must meet AT LEAST ONE clinical inclusion criterion:
- Adult patients = 65 years of age
- Female gender
- Troponin positive acute coronary syndrome
- Established vascular disease defined as previous MI, documented PAD or CAD/PAD revascularization
- Diabetes mellitus treated with medications or insulin
- Chronic kidney disease defined as an estimated glomerular filtration rate (eGFR) <60 ml/min/1.73m2 or creatinine clearance (CrCl) <60 ml/min
Must meet AT LEAST ONE angiographic inclusion criterion:
- Multivessel coronary artery disease (CAD)
- Target lesion requiring total stent length >30mm
- Thrombotic target lesion(s)
- Bifurcation lesion(s) 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3600

Exclusion Criteria

Subjects should not enter the study if any of the following exclusion criteria are met:
- Under 18 years of age
- Contraindication to aspirin, as listed in Appendix D
- Contraindication to ticagrelor, as listed in Appendix E
- 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. acute gastrointestinal ulcer or history of chronic gastrointestinal ulceration, gastrointestinal pathology with a raised risk for bleeding, malignancies with a raised risk for bleeding)
- Salvage PCI or STEMI presentation.
- Liver cirrhosis
- Life expectancy < 1 year
- Unable or unwilling to provide informed consent
- Women of child bearing potential as defined below:
A woman is considered of childbearing potential (WOBCP) following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified