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

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 that could block blood flow to the heart. This study will look to determine the effectiveness and safety of ticagrelor alone, compared to ticagrelor plus aspirin in reducing clinically relevant bleeding and in reducing ischemic adverse events among high-risk patients who have had a percutaneous intervention with at least one drug-eluting stent. A patient is considered high-risk if they meet certain clinical and/or anatomic criteria. Up to 9000 subjects will be enrolled at the time of their index PCI. Subjects meeting randomization eligibility criteria at 3 months post enrollment will be randomized to either ticagrelor plus aspirin or ticagrelor plus placebo for an additional 12 months.

I'M INTERESTED

This research study is led by Dr. Gregory Giugliano.

Contact: Annette Scarnici, RN, CCRC, 413-794-9076

Participation details:

July 01, 2015
BH-15-236
Heart
Baystate Medical Center, 759 Chestnut St, Springfield, MA

Inclusion Criteria:

  • 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.
  • Adult patients ≥ 65 years of age
  • Female gender
  • Diabetes mellitus treated with medications (oral hypoglycemic, subcutaneous injection of insulin)    

Exclusion Criteria:

  • Under 18 years of age
  • Planned surgery within 90 days
  • Prior stroke
  • 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.
Follow-up clinic visits will be performed at 3 months, 9 months and 15 months post enrollment.
Active
Interventional (Clinical Trial), Randomized
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