TWILIGHT Study - Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Interventio

Phase 1

• Conditions: Bleeding among high-risk patients with percutanous coronary intervention with at least one drug-eluting stent; MedDRA version: 19.0 Level: PT Classification code 10065608 Term: Percutaneous coronary intervention System Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-005498-35-AT
• Lead Sponsor: The Office of Interventional Cardiovascular Research and 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: 2016-01-11
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• 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

* The diagnosis of multivessel CAD may be established with the angiogram performed at enrollment or an earlier angiogram. A vessel previously treated with either a stent or bypass graft may also be considered diseased for purposes of meeting the multivessel CAD angiographic inclusion criterion.
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
- 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. 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