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

NCT02270242 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: GCO 14-1383
• Study Type: interventional
• Target: 9,006
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease; Interventional Cardiology

Keywords

PCI; DAPT; ticagrelor; aspirin

Outcome Measures

Primary Outcomes (1)

• Number of Participants With BARC Type 2, 3, or 5

  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).

  12 months after randomization

Secondary Outcomes (1)

• Number of Participants With Ischemic Episode

  12 months after randomization

Study Arms (2)

Aspirin + Ticagrelor

ACTIVE COMPARATOR

enteric coated aspirin 81mg-100mg daily p.o. for 12 months and ticagrelor 90mg tablet bid for 12 months

Drug: Aspirin; Drug: ticagrelor

Placebo + Ticagrelor

PLACEBO COMPARATOR

placebo pill daily p.o. for 12 months - match for enteric coated aspirin 81mg-100mg and ticagrelor 90mg tablet bid for 12 months

Drug: Placebo; Drug: ticagrelor

Interventions

Aspirin DRUG

Also known as: Ecotrin

Aspirin + Ticagrelor

Placebo DRUG

Placebo + Ticagrelor

ticagrelor DRUG

Also known as: Brilinta, Brilique

Aspirin + Ticagrelor; Placebo + Ticagrelor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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
• Under 18 years of age
• Contraindication to aspirin
• Contraindication to ticagrelor

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• AstraZeneca: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (38)

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• Baber U, Dangas G, Angiolillo DJ, Cohen DJ, Sharma SK, Nicolas J, Briguori C, Cha JY, Collier T, Dudek D, Dzavik V, Escaned J, Gil R, Gurbel P, Hamm CW, Henry T, Huber K, Kastrati A, Kaul U, Kornowski R, Krucoff M, Kunadian V, Marx SO, Mehta S, Moliterno D, Ohman EM, Oldroyd K, Sardella G, Sartori S, Shlofmitz R, Steg PG, Weisz G, Witzenbichler B, Han YL, Pocock S, Gibson CM, Mehran R. Ticagrelor alone vs. ticagrelor plus aspirin following percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndromes: TWILIGHT-ACS. Eur Heart J. 2020 Oct 1;41(37):3533-3545. doi: 10.1093/eurheartj/ehaa670.

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• Angiolillo DJ, Baber U, Sartori S, Briguori C, Dangas G, Cohen DJ, Mehta SR, Gibson CM, Chandiramani R, Huber K, Kornowski R, Weisz G, Kunadian V, Oldroyd KG, Ya-Ling H, Kaul U, Witzenbichler B, Dudek D, Sardella G, Escaned J, Sharma S, Shlofmitz RA, Collier T, Pocock S, Mehran R. Ticagrelor With or Without Aspirin in High-Risk Patients With Diabetes Mellitus Undergoing Percutaneous Coronary Intervention. J Am Coll Cardiol. 2020 May 19;75(19):2403-2413. doi: 10.1016/j.jacc.2020.03.008. Epub 2020 Mar 30.

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• Mehran R, Baber U, Sharma SK, Cohen DJ, Angiolillo DJ, Briguori C, Cha JY, Collier T, Dangas G, Dudek D, Dzavik V, Escaned J, Gil R, Gurbel P, Hamm CW, Henry T, Huber K, Kastrati A, Kaul U, Kornowski R, Krucoff M, Kunadian V, Marx SO, Mehta SR, Moliterno D, Ohman EM, Oldroyd K, Sardella G, Sartori S, Shlofmitz R, Steg PG, Weisz G, Witzenbichler B, Han YL, Pocock S, Gibson CM. Ticagrelor with or without Aspirin in High-Risk Patients after PCI. N Engl J Med. 2019 Nov 21;381(21):2032-2042. doi: 10.1056/NEJMoa1908419. Epub 2019 Sep 26.

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MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Aspirin; Ticagrelor

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Limitations and Caveats

Limitations include lack of power to detect differences in the risk of important yet rare clinical events, e.g stent thrombosis and stroke; and trial may not be generalizable to all patients undergoing PCI due to high risk criteria.

Results Point of Contact

• Title: Dr. Roxana Mehran
• Organization: Icahn School of Medicine at Mount Sinai

roxana.mehran@mountsinai.org

212-659-9691

Study Officials

• Roxana Mehran, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Usman Baber, MD

  Icahn School of Medicine at Mount Sinai

  STUDY DIRECTOR

• Roxana Mehran, MD

  Icahn School of Medicine at Mount Sinai

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 15, 2014
• First Posted: October 21, 2014
• Study Start: July 1, 2015
• Primary Completion: July 10, 2019
• Study Completion: July 10, 2019
• Last Updated: January 13, 2021
• Results First Posted: August 19, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)