TWILIGHT Study: Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention.

Phase 1

• Conditions: Bleeding among high-risk patients with Percutanous coronary intervention with at least one drug-eluting stent.; MedDRA version: 18.1Level: PTClassification code 10065608Term: Percutaneous coronary interventionSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-005498-35-GB
• Lead Sponsor: Mount Sinai

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-24
• Last Update Posted: 20 June 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 9000

Inclusion Criteria

High-risk patients who have undergone successful percutaneous coronary intervention(PCI) with at least one locally approved drug eluting stent AND discharged on DAPT with aspirin and ticagrelor of at least 3 months intended duration.

Enrollment into the study will require meeting at least one clinical inclusion AND at least one angiographic inclusion.

Clinical Inclusion Criteria (must meet at least one):

•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 (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

Are the trial subjects under 18? no
Number of subjects for this age range: 0
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

•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)
•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

Study & Design

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