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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02270242
Recruitment Status : Completed
First Posted : October 21, 2014
Results First Posted : August 19, 2020
Last Update Posted : August 19, 2020
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Roxana Mehran, Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE October 15, 2014
First Posted Date  ICMJE October 21, 2014
Results First Submitted Date  ICMJE July 10, 2020
Results First Posted Date  ICMJE August 19, 2020
Last Update Posted Date August 19, 2020
Study Start Date  ICMJE July 2015
Actual Primary Completion Date July 10, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2020)
Number of Participants With BARC Type 2, 3, or 5 [ Time Frame: 12 months after randomization ]
Number of participants with first occurrence of clinically relevant bleeding episode, defined as Bleeding Academic Research Consortium (BARC) Types 2, 3 or 5 bleeding. BARC bleeding types range from 0 (no bleeding) to 5 (fatal bleeding).
Original Primary Outcome Measures  ICMJE
 (submitted: October 17, 2014)
Bleeding episode [ Time Frame: 12 months ]
the time to first occurrence of clinically relevant bleeding, defined as Bleeding Academic Research Consortium (BARC) Types 2, 3 or 5 bleeding.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2020)
Number of Participants With Ischemic Episode [ Time Frame: 12 months after randomization ]
Number of participants with first occurrence of confirmed all-cause death, non-fatal myocardial infarction or stroke.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2014)
Ischemic episode [ Time Frame: 12 months ]
the time to first occurrence of confirmed cardiovascular death, non-fatal myocardial infarction, ischemic stroke or ischemia-driven revascularization
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention
Official Title  ICMJE Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention
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 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. Follow-up clinic visits will be performed at 3 months, 9 months and 15 months post enrollment.

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 with aspirin and ticagrelor of at least 3 months intended duration from centers still to be determined in the U.S., Canada, Europe and Asia. The primary objective of this study is to determine the impact of antiplatelet monotherapy with ticagrelor alone versus DAPT with ticagrelor plus aspirin for 12 months in reducing clinically relevant bleeding (efficacy) among high-risk patients undergoing PCI who have completed a 3-month course of aspirin plus ticagrelor. The secondary objective of this study is to determine the impact of antiplatelet monotherapy with ticagrelor alone versus DAPT with ticagrelor plus aspirin for 12 months in reducing major ischemic adverse events (safety) among high-risk patients undergoing PCI who have completed a 3-month course of aspirin plus ticagrelor.

Exploratory objectives include assessing the comparative safety and efficacy of the different DAPT regimens for individual components of the primary efficacy and secondary safety objectives.

The primary analysis for TWILIGHT will be performed independently by the London School of Hygiene and Tropical Medicine

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Cardiovascular Disease
  • Interventional Cardiology
Intervention  ICMJE
  • Drug: Aspirin
    Other Name: Ecotrin
  • Drug: Placebo
  • Drug: ticagrelor
    Other Names:
    • Brilinta
    • Brilique
Study Arms  ICMJE
  • Active Comparator: Aspirin + Ticagrelor
    enteric coated aspirin 81mg-100mg daily p.o. for 12 months and ticagrelor 90mg tablet bid for 12 months
    Interventions:
    • Drug: Aspirin
    • Drug: ticagrelor
  • Placebo Comparator: Placebo + Ticagrelor
    placebo pill daily p.o. for 12 months - match for enteric coated aspirin 81mg-100mg and ticagrelor 90mg tablet bid for 12 months
    Interventions:
    • Drug: Placebo
    • Drug: ticagrelor
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 29, 2019)
9006
Original Estimated Enrollment  ICMJE
 (submitted: October 17, 2014)
9000
Actual Study Completion Date  ICMJE July 10, 2019
Actual Primary Completion Date July 10, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
  • Enrollment into the study will require meeting at least one clinical inclusion, one angiographic inclusion and none of the exclusion criteria.

Clinical Inclusion Criteria:

  • 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:

  • 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 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. 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02270242
Other Study ID Numbers  ICMJE GCO 14-1383
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Roxana Mehran, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Icahn School of Medicine at Mount Sinai
Collaborators  ICMJE AstraZeneca
Investigators  ICMJE
Principal Investigator: Roxana Mehran, MD Icahn School of Medicine at Mount Sinai
Study Director: Usman Baber, MD Icahn School of Medicine at Mount Sinai
Study Chair: Roxana Mehran, MD Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP