Platelet Sub-study of the TWILIGHT Trial

NCT04001374 | Completed FDA Drug

• 1 other identifier: GCO 15-0769
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

TWILIGHT study is a multicenter RCT comparing treatment with ticagrelor alone versus ticagrelor plus aspirin in high-risk patients after PCI. All patients will receive DAPT (ticagrelor plus aspirin) for the initial 3 months post-PCI and then be randomized to either Ticagrelor alone OR Ticagrelor plus Aspirin DAPT. To investigate the pharmacodynamic effects of the two treatments in this trial, a 'Platelet Sub-study' will be conducted only at the Mount Sinai Medical Center. The sub-study will recruit randomized patients from the TWILIGHT Trial at Mount Sinai and conduct specialized blood tests at randomization and one month thereafter. The aim of the Platelet Sub-study is to compare the antithrombotic effects of Ticagrelor alone versus Ticagrelor plus Aspirin using an ex vivo model of thrombosis (Badimon Chamber).

Conditions

Coronary Artery Disease; Myocardial Infarction

Keywords

Thrombosis; Platelets; Platelet Aggregation; Blood Thrombogenicity

Outcome Measures

Primary Outcomes (1)

• Thrombus size (Badimon Chamber)

  Thrombus area measured 1-6 months after randomization

  1-6 months after randomization

Secondary Outcomes (1)

• Platelet aggregation

  1-6 months after randomization

Study Arms (2)

Ticagrelor

Ticagrelor 90mg tablet bid for 12 months

Drug: Ticagrelor

Ticagrelor + ASA

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

Drug: Ticagrelor; Drug: ASA

Interventions

Ticagrelor DRUG

90mg tablet bid for 12 months

Ticagrelor; Ticagrelor + ASA

ASA DRUG

enteric coated aspirin 81mg-100mg daily p.o. for 12 months

Ticagrelor + ASA

Eligibility Criteria

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

Study Population

Randomized subjects from the TWILIGHT trial treated at Mount Sinai Medical Center

You may qualify if:

• Patients enrolled in the TWILIGHT trial:
• Adult patients ≥ 65 years of age
• Troponin (+) acute coronary syndrome
• Female gender
• 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

You may not qualify if:

• Patients not eligible to participate in the TWILIGHT trial:
• 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)
• Emergent or salvage PCI or STEMI presentation.
• Liver cirrhosis
• Life expectancy \< 1 year
• Unable or unwilling to provide informed consent
• Women of child bearing potential (as determined by hospital standard of care)

Sponsors & Collaborators

• Juan Badimon: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

• Baber U, Zafar MU, Dangas G, Escolar G, Angiolillo DJ, Sharma SK, Kini AS, Sartori S, Joyce L, Vogel B, Farhan S, Gurbel P, Gibson CM, Fuster V, Mehran R, Badimon JJ. Ticagrelor With or Without Aspirin After PCI: The TWILIGHT Platelet Substudy. J Am Coll Cardiol. 2020 Feb 18;75(6):578-586. doi: 10.1016/j.jacc.2019.11.056.

  PMID: 32057371 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Infarction; Thrombosis

Interventions

Ticagrelor

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Juan Badimon, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine and Director of AtheroThrombosis Research Lab

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: June 28, 2019
• Study Start: June 28, 2015
• Primary Completion: February 28, 2018
• Study Completion: February 28, 2018
• Last Updated: February 26, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)