Acute Coronary SyndromePhase 4NCT01916902
Effect of Pretreatment With Ticagrelor on Residual Thrombus After PCI in Patients Presenting With ACS in Comparison With Delayed Treatment at the Time of PCI: an OCT Study
A Phase 4 study testing Ticagrelor- Delayed Administration, Ticagrelor- Immediate Administration and Optical Coherence Tomography in people with Acute Coronary Syndrome and Coronary Artery Disease, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Subjects presenting with probable acute coronary syndromes scheduled for cardiac catheterization will be enrolled in this study. Consented subjects will be randomized to receive ticagrelor started with a loading dose immediately after enrollment versus receiving a loading dose of ticagrelor during cardiac… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Acute Coronary Syndrome, Coronary Artery Disease
- What is being tested?
- Ticagrelor- Delayed Administration, Ticagrelor- Immediate Administration and Optical Coherence Tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Feb 2015
- Phase
- Phase 4
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient Characteristics:
- Males and non-pregnant females > or equal to 18 and < or equal to 79 years of age presenting with suspected acute coronary syndrome (unstable angina or NSTEMI)
- Patients likely to be scheduled to undergo coronary angiography with possible percutaneous coronary intervention (PCI)
- Lesion Characteristics on Diagnostic Coronary Angiography:
- De novo lesions in native coronary arteries found by diagnostic coronary angiography
- Angiographic stenosis <100%
- Reference vessel diameter 2.5 mm - 4.0 mm by visual estimation
Who cannot join
- Patient Specific Exclusion Criteria:
- Subjects who are unable or unwilling to sign the informed consent form.
- Subjects being treated with anti-platelet medications other than aspirin prior to diagnostic catheterization including glycoprotein IIb/IIIa inhibitors.
- Subjects with serious co-morbid conditions that in judgment of the investigator preclude inclusion in this study
- Subjects with NYHA class III or IV heart failure or known left ventricular ejection fraction < 30%.
- Subjects with an ST elevation myocardial infarction.
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- Subjects with hemodynamic or electrical instability (including shock).
- Subjects diagnosed with severe, non-catheter-related coronary artery spasm.
- Subjects who are or may be pregnant.
- Subjects with known allergies to contrast media.
- Subjects with eGFR < 60 ml/min/1.73m2.
- Subjects currently taking oral anticoagulants with an absolute contraindication to discontinuation of anticoagulation.
- History of TIA or stroke < 6 months.
- History of hemorrhagic stroke.
- Hepatic insufficiency defined as liver cirrhosis, AST/ALT/Alkaline Phosphatase greater than 3 times the upper limit of normal or hyperbilirubinemia.
- Cardiac catheterization scheduled within 4 hours of randomization or more then 72 hours after randomization.
- Lesion Specific Exclusion Criteria. These exclusion criteria apply to the target lesion to be imaged by OCT.
- Lesions located in the left main coronary artery
- Lesions that are heavily calcified
- Lesions where OCT cannot be performed due to technical difficulties
- Other lesions that the investigator deems inappropriate for the procedure such as sites with excessive tortuosity or low flow by TIMI grade.
- Lesions in saphenous vein grafts or arterial conduits.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Effect of Pretreatment With Ticagrelor on Residual Thrombus After Percutaneous Coronary Intervention (PCI) in Patients Presenting With Acute Coronary Syndrome in Comparison With Delayed Treatment at the Time of PCI: an Optical Coherence Tomography Study
Subjects presenting with probable acute coronary syndromes scheduled for cardiac catheterization will be enrolled in this study. Consented subjects will be randomized to receive ticagrelor started with a loading dose immediately after enrollment versus receiving a loading dose of ticagrelor during cardiac catheterization after diagnostic angiography but prior to stenting. Optical coherence tomography (OCT) will be performed after stenting and the volume of thrombus within the new stent will be measured and compared between the groups.
- Conditions
- Acute Coronary Syndrome, Coronary Artery Disease
- Being tested
- Ticagrelor- Delayed Administration, Ticagrelor- Immediate Administration, Optical Coherence Tomography
- Keywords
- Optical Coherence Tomography, Ticagrelor
- Medical subject headings
- Acute Coronary Syndrome, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ticagrelor- Delayed AdministrationDrug
Subjects are randomized to receive ticagrelor immediately after enrollment versus at the time of cardiac catheterization. OCT is performed prior to and after coronary artery stenting.
Ticagrelor- Immediate AdministrationDrug
Subjects are randomized to receive ticagrelor immediately after enrollment versus at the time of cardiac catheterization. OCT is performed prior to and after coronary artery stenting.
Optical Coherence TomographyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor- Delayed Administration | Active comparator | Subjects receive 180 mg of ticagrelor during cardiac catheterization after diagnostic angiography and prior to stenting. OCT is performed prior to and after coronary artery stenting. Receives: Drug: Ticagrelor- Delayed Administration; Procedure: Optical Coherence Tomography |
| Ticagrelor- Immediate Administration | Active comparator | Subjects receive 180 mg of ticagrelor immediately after study enrollment. OCT is performed prior to and after coronary artery stenting. Receives: Drug: Ticagrelor- Immediate Administration; Procedure: Optical Coherence Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total thrombus burden as measured by the volume of in-stent thrombus quantified by planimetry.
The total thrombus burden measured on OCT images will be assessed. The volume of in-stent thrombus will be quantified by planimetry.
Measured: Thrombus burden will be measured at the end of the coronary artery stenting procedure.
Secondary outcomes (2)
PRI (platelet reactivity index) as measured bu the PLT-VASP assay.
The extent of platelet inhibition will be measured by PLT-VASP and VerifyNow P2Y12 assays.
Measured: PRI iwill be measured at the time of OCT image acquisition.
P2Y12 Reaction Units as measured by the VerifyNow P2Y12 assay.
The extent of platelet inhibition will be measured by PLT-VASP and VerifyNow P2Y12 assays.
Measured: P2Y12 will be measured at the time of OCT image acquisition.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study startFeb 2014
- Primary completionFeb 2015 (estimated)
Why it stopped: Despite a large number of patients screened, very few met eligibility guidelines.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital
- Investigators
- Ik-Kyung Jang, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916902
- Sponsor's protocol ID
- 2013P001322
- Status last verified
- May 2014
- First submitted
- 2 Aug 2013
- Last updated
- 26 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pretreatment With Ticagrelor on Residual Thrombus After Percutaneous Coronary Intervention (PCI) in Patients Presenting With Acute Coronary Syndrome in Comparison With Delayed Treatment at the Time of PCI: an Optical Coherence Tomography Study
- ClinicalTrials.gov ID
- NCT01916902
- Acronym / sponsor ID
- 2013P001322
- Conditions
- Acute Coronary Syndrome, Coronary Artery Disease
- Keywords
- Optical Coherence Tomography, Ticagrelor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Despite a large number of patients screened, very few met eligibility guidelines.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Feb 2014
- Primary completion
- Feb 2015 (estimated)
- First posted
- 6 Aug 2013 (estimated)
- 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.
Subjects presenting with probable acute coronary syndromes scheduled for cardiac catheterization will be enrolled in this study. Consented subjects will be randomized to receive ticagrelor started with a loading dose immediately after enrollment versus receiving a loading dose of ticagrelor during cardiac catheterization after diagnostic angiography but prior to stenting. Optical coherence tomography (OCT) will be performed after stenting and the volume of thrombus within the new stent will be measured and compared between the groups.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor- Delayed Administration | Active comparator | Drug: Ticagrelor- Delayed Administration, Procedure: Optical Coherence TomographySubjects receive 180 mg of ticagrelor during cardiac catheterization after diagnostic angiography and prior to stenting. OCT is performed prior to and after coronary artery stenting. |
| Ticagrelor- Immediate Administration | Active comparator | Drug: Ticagrelor- Immediate Administration, Procedure: Optical Coherence TomographySubjects receive 180 mg of ticagrelor immediately after study enrollment. OCT is performed prior to and after coronary artery stenting. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and non-pregnant females > or equal to 18 and < or equal to 79 years of age presenting with suspected acute coronary syndrome (unstable angina or NSTEMI)
- Patients likely to be scheduled to undergo coronary angiography with possible percutaneous coronary intervention (PCI)
- De novo lesions in native coronary arteries found by diagnostic coronary angiography
- Angiographic stenosis <100%
- Reference vessel diameter 2.5 mm - 4.0 mm by visual estimation
Key exclusion criteria (22 listed)
- Subjects who are unable or unwilling to sign the informed consent form.
- Subjects being treated with anti-platelet medications other than aspirin prior to diagnostic catheterization including glycoprotein IIb/IIIa inhibitors.
- Subjects with serious co-morbid conditions that in judgment of the investigator preclude inclusion in this study
- Subjects with NYHA class III or IV heart failure or known left ventricular ejection fraction < 30%.
- Subjects with an ST elevation myocardial infarction.
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 |
|---|---|---|
| Ticagrelor- Delayed AdministrationSubjects are randomized to receive ticagrelor immediately after enrollment versus at the time of cardiac catheterization. OCT is performed prior to and after coronary artery stenting. | Drug | Ticagrelor- Delayed Administration |
| Ticagrelor- Immediate AdministrationSubjects are randomized to receive ticagrelor immediately after enrollment versus at the time of cardiac catheterization. OCT is performed prior to and after coronary artery stenting. | Drug | Ticagrelor- Immediate Administration |
| Optical Coherence Tomography | Procedure or surgery | Ticagrelor- Delayed Administration, Ticagrelor- Immediate Administration |
Primary outcome
Total thrombus burden as measured by the volume of in-stent thrombus quantified by planimetry.
Time frame: Thrombus burden will be measured at the end of the coronary artery stenting procedure.
The total thrombus burden measured on OCT images will be assessed. The volume of in-stent thrombus will be quantified by planimetry.
2 secondary outcomes
PRI (platelet reactivity index) as measured bu the PLT-VASP assay.
Time frame: PRI iwill be measured at the time of OCT image acquisition.
P2Y12 Reaction Units as measured by the VerifyNow P2Y12 assay.
Time frame: P2Y12 will be measured at the time of OCT image acquisition.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2014.
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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.
Ik-Kyung Jang, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ticagrelor- Delayed Administration, Ticagrelor- Immediate Administration and Optical Coherence Tomography in people with Acute Coronary Syndrome and Coronary Artery Disease, run by Massachusetts General Hospital 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 7 inclusion and 22 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: withdrawn, as of the sponsor's last update on 26 May 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Total thrombus burden as measured by the volume of in-stent thrombus quantified by planimetry. (time frame: Thrombus burden will be measured at the end of the coronary artery stenting procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2014.