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Platelet Sub-study of the TWILIGHT Trial

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ClinicalTrials.gov Identifier: NCT04001374
Recruitment Status : Completed
First Posted : June 28, 2019
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Juan Badimon, Icahn School of Medicine at Mount Sinai

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).


Condition or disease Intervention/treatment
Coronary Artery Disease Myocardial Infarction Drug: Ticagrelor Drug: ASA

Detailed Description:
The present study will enroll a cohort of randomized patients from the TWILIGHT trial at the Mount Sinai Medical Center. These subjects will undergo blood sampling and measurement of thrombotic indices at the time of randomization and 1-6 months thereafter.

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Platelet Sub-study of the TWILIGHT Trial
Actual Study Start Date : June 28, 2015
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ticagrelor

Group/Cohort Intervention/treatment
Ticagrelor
Ticagrelor 90mg tablet bid for 12 months
Drug: Ticagrelor
90mg tablet bid for 12 months

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

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




Primary Outcome Measures :
  1. Thrombus size (Badimon Chamber) [ Time Frame: 1-6 months after randomization ]
    Thrombus area measured 1-6 months after randomization


Secondary Outcome Measures :
  1. Platelet aggregation [ Time Frame: 1-6 months after randomization ]
    Platelet aggregation assessed using Multiplate Analyzer 1-6 months after randomization


Biospecimen Retention:   Samples Without DNA
Plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Randomized subjects from the TWILIGHT trial treated at Mount Sinai Medical Center
Criteria

Inclusion Criteria:

Patients enrolled in the TWILIGHT trial:

Clinical Inclusion Criteria (must meet at least one):

  • 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

Angiographic Inclusion Criteria (must meet at least one):

  • 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:

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)
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04001374


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Juan Badimon
Investigators
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Principal Investigator: Juan Badimon, PhD Icahn School of Medicine at Mount Sinai

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Responsible Party: Juan Badimon, Professor of Medicine and Director of AtheroThrombosis Research Lab, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT04001374     History of Changes
Other Study ID Numbers: GCO 15-0769
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Juan Badimon, Icahn School of Medicine at Mount Sinai:
Thrombosis
Platelets
Platelet Aggregation
Blood Thrombogenicity
Additional relevant MeSH terms:
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Platelet Aggregation Inhibitors
Coronary Artery Disease
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Ticagrelor
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs