Status:
COMPLETED
Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
AstraZeneca
Conditions:
Cardiovascular Disease
Interventional Cardiology
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the use of ticagrelor alone versus ticagrelor and aspirin together. Both ticagrelor and aspirin stop platelets from sticking together and forming a blood clot t...
Detailed Description
This is a multicenter, prospective, blinded dual-arm study. Up to 9000 high-risk patients who have undergone successful PCI with at least one locally approved drug eluting stent discharged on DAPT wit...
Eligibility Criteria
Inclusion
- High-risk patients who have undergone successful PCI with at least one locally approved drug eluting stent discharged on DAPT with aspirin and ticagrelor of at least 3 months intended duration will be eligible for the TWILIGHT study.
- Enrollment into the study will require meeting at least one clinical inclusion, one angiographic inclusion and none of the exclusion criteria.
- Clinical
- 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
- 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
Exclusion
- 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. Defined: a woman is considered 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
Key Trial Info
Start Date :
July 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2019
Estimated Enrollment :
9006 Patients enrolled
Trial Details
Trial ID
NCT02270242
Start Date
July 1 2015
End Date
July 10 2019
Last Update
January 13 2021
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029