title: Ticagrelor with aspirin or alone in high-risk patients after coronary intervention: Rationale and design of the TWILIGHT study.
abstract: BACKGROUND
  Dual antiplatelet therapy (DAPT) is necessary to prevent thrombosis yet increases bleeding after percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Antiplatelet monotherapy with a potent P2Y12receptor antagonist may reduce bleeding while maintaining anti thrombotic efficacy compared with conventional DAPT.
  
  
  METHODS
  TWILIGHT is a randomized, double-blind placebo-controlled trial evaluating the comparative efficacy and safety of antiplatelet monotherapy versus DAPT in up to 9000 high-risk patients undergoing PCI with DES. Upon enrollment after successful PCI, all patients will be treated with open label low-dose aspirin (81-100 mg daily) plus ticagrelor (90 mg twice daily) for 3 months. Event-free patients will then be randomized in a double-blind fashion to low-dose aspirin versus matching placebo with continuation of open-label ticagrelor for an additional 12 months. The primary hypothesis is that a strategy of ticagrelor monotherapy will be superior with respect to the primary endpoint of bleeding academic research consortium type 2, 3 or 5, while maintaining non-inferiority for ischemic events compared with ticagrelor plus ASA.
  
  
  CONCLUSIONS
  TWILIGHT is the largest study to date that is specifically designed and powered to demonstrate reductions in bleeding with ticagrelor monotherapy versus ticagrelor plus ASA beyond 3 months post-procedure in a high-risk PCI population treated with DES. The trial will provide novel insights with respect to the potential role of ticagrelor monotherapy as an alternative for long-term platelet inhibition in a broad population of patients undergoing PCI with DES.
authors.affiliation: The Zena and Michael A. Wiener Cardiovascular Institute, The Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1030, New York, NY.
authors.forename: Usman
authors.initials: U
authors.lastname: Baber
authors.affiliation: The Zena and Michael A. Wiener Cardiovascular Institute, The Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1030, New York, NY.
authors.forename: George
authors.initials: G
authors.lastname: Dangas
authors.affiliation: Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, Mo.
authors.forename: David J
authors.initials: DJ
authors.lastname: Cohen
authors.affiliation: Beth Israel Deaconess Medical Center, Boston, MA.
authors.forename: C Michael
authors.initials: CM
authors.lastname: Gibson
authors.affiliation: Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.
authors.forename: Shamir R
authors.initials: SR
authors.lastname: Mehta
authors.affiliation: University of Florida College of Medicine-Jacksonville, Jacksonville, FL.
authors.forename: Dominick J
authors.initials: DJ
authors.lastname: Angiolillo
authors.affiliation: London School of Hygiene and Tropical Medicine, London, UK.
authors.forename: Stuart J
authors.initials: SJ
authors.lastname: Pocock
authors.affiliation: Duke University School of Medicine, Durham, NC.
authors.forename: Mitchell W
authors.initials: MW
authors.lastname: Krucoff
authors.affiliation: Deutsches Herzzentrum, Technische Universität, Munich, Germany.
authors.forename: Adnan
authors.initials: A
authors.lastname: Kastrati
authors.affiliation: Duke University School of Medicine, Durham, NC.
authors.forename: E Magnus
authors.initials: EM
authors.lastname: Ohman
authors.affiliation: Hôpital Bichat-Claude Bernard, Paris, France.
authors.forename: Philippe Gabriel
authors.initials: PG
authors.lastname: Steg
authors.affiliation: The Zena and Michael A. Wiener Cardiovascular Institute, The Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1030, New York, NY.
authors.forename: Juan
authors.initials: J
authors.lastname: Badimon
authors.affiliation: The Zena and Michael A. Wiener Cardiovascular Institute, The Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1030, New York, NY.
authors.forename: M Urooj
authors.initials: MU
authors.lastname: Zafar
authors.affiliation: The Zena and Michael A. Wiener Cardiovascular Institute, The Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1030, New York, NY.
authors.forename: Jaya
authors.initials: J
authors.lastname: Chandrasekhar
authors.affiliation: The Zena and Michael A. Wiener Cardiovascular Institute, The Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1030, New York, NY.
authors.forename: Samantha
authors.initials: S
authors.lastname: Sartori
authors.affiliation: The Zena and Michael A. Wiener Cardiovascular Institute, The Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1030, New York, NY.
authors.forename: Melissa
authors.initials: M
authors.lastname: Aquino
authors.affiliation: The Zena and Michael A. Wiener Cardiovascular Institute, The Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1030, New York, NY. Electronic address: roxana.mehran@mountsinai.org.
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
mesh_terms: D054058:Acute Coronary Syndrome / Q000628:therapy*; D000241:Adenosine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000368:Aged; D001241:Aspirin / Q000008:administration & dosage / Q000009:adverse effects; D023903:Coronary Restenosis / Q000209:etiology / Q000517:prevention & control*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000379:methods; D054855:Drug-Eluting Stents; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced / Q000517:prevention & control; D006801:Humans; D008297:Male; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000379:methods; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D020379:Risk Adjustment / Q000379:methods; D000077486:Ticagrelor; D016896:Treatment Outcome
chemical_list: D010975:Platelet Aggregation Inhibitors; D000077486:Ticagrelor; D000241:Adenosine; D001241:Aspirin