Coronary Artery DiseaseNCT04001374
Platelet Sub-study of the TWILIGHT Trial
An observational study of Coronary Artery Disease and Myocardial Infarction, run by Juan Badimon at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Myocardial Infarction
- What is being tested?
- Ticagrelor and ASA
- Type of treatment
- Pill or oral medicine
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2015to 28 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Randomized subjects from the TWILIGHT trial treated at Mount Sinai Medical Center
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
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).
Read the 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.
- Conditions
- Coronary Artery Disease, Myocardial Infarction
- Being tested
- Ticagrelor, ASA
- Keywords
- Thrombosis, Platelets, Platelet Aggregation, Blood Thrombogenicity
- Medical subject headings
- Coronary Artery Disease, Myocardial Infarction, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicagrelorDrug
90mg tablet bid for 12 months
ASADrug
enteric coated aspirin 81mg-100mg daily p.o. for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor | Ticagrelor 90mg tablet bid for 12 months Receives: Drug: Ticagrelor | |
| Ticagrelor + ASA | Ticagrelor 90mg tablet bid for 12 months and enteric coated aspirin 81mg-100mg daily p.o. for 12 months Receives: Drug: Ticagrelor; Drug: ASA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombus size (Badimon Chamber)
Thrombus area measured 1-6 months after randomization
Measured: 1-6 months after randomization
Secondary outcomes (1)
Platelet aggregation
Platelet aggregation assessed using Multiplate Analyzer 1-6 months after randomization
Measured: 1-6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start28 Jun 2015
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juan Badimon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Juan Badimon, Icahn School of Medicine at Mount Sinai
- Investigators
- Juan Badimon, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001374
- Sponsor's protocol ID
- GCO 15-0769
- Status last verified
- Feb 2020
- First submitted
- 26 Jun 2019
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32057371
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Sub-study of the TWILIGHT Trial
- ClinicalTrials.gov ID
- NCT04001374
- Acronym / sponsor ID
- GCO 15-0769
- Conditions
- Coronary Artery Disease, Myocardial Infarction
- Keywords
- Thrombosis, Platelets, Platelet Aggregation, Blood Thrombogenicity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Juan BadimonUniversity, hospital or other
- Study start
- 28 Jun 2015 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 28 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor | – | Drug: TicagrelorTicagrelor 90mg tablet bid for 12 months |
| Ticagrelor + ASA | – | Drug: Ticagrelor, Drug: ASATicagrelor 90mg tablet bid for 12 months and enteric coated aspirin 81mg-100mg daily p.o. for 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Randomized subjects from the TWILIGHT trial treated at Mount Sinai Medical Center
Key inclusion criteria (15 listed)
- 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)
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ticagrelor90mg tablet bid for 12 months | Drug | Ticagrelor, Ticagrelor + ASA |
| ASAenteric coated aspirin 81mg-100mg daily p.o. for 12 months | Drug | Ticagrelor + ASA |
Primary outcome
Thrombus size (Badimon Chamber)
Time frame: 1-6 months after randomization
Thrombus area measured 1-6 months after randomization
1 secondary outcome
Platelet aggregation
Time frame: 1-6 months after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Results publication: PubMed 32057371Baber 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Badimon, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Myocardial Infarction, run by Juan Badimon at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thrombus size (Badimon Chamber) (time frame: 1-6 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04001374, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2020.