Percutaneous Coronary InterventionPhase 4NCT02402491
Twelve vs 24 Months of Dual Antiplatelet Therapy in Patients With Coronary Revascularization for In-stent Restenosis
A Phase 4 study testing 12 months of P2Y12 receptor antagonist, 24 months of P2Y12 receptor antagonist and Aspirin in people with Percutaneous Coronary Intervention, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
Patients undergoing the percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) are enrolled. All patients will be randomized to receive either 12 months or 24 months of dual antiplatelet therapy with a P2Y12 receptor antagonist in addition to aspirin, all patients continue receiving aspirin… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Percutaneous Coronary Intervention
- What is being tested?
- 12 months of P2Y12 receptor antagonist, 24 months of P2Y12 receptor antagonist and Aspirin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Jun 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects 18-80 years of age
- Undergoing percutaneous intervention with stent deployment for the treatment of in-stent restenosis
Who cannot join
- Pregnant women
- Planned surgery necessitating discontinuation of antiplatelet therapy within the 24 months after enrollment
- Current medical condition with a life expectancy of <2 years
- Concurrent enrollment in another device or drug study whose protocol specifically rules out concurrent enrollment
- Subjects on warfarin or similar anticoagulant therapy
- Subjects with hypersensitivity or allergies to one of the drugs
- Subjects unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Twelve Versus 24 Months of Dual Antiplatelet Therapy in Patients With Percutaneous Coronary Intervention for In-stent Restenosis
Patients undergoing the percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) are enrolled. All patients will be randomized to receive either 12 months or 24 months of dual antiplatelet therapy with a P2Y12 receptor antagonist in addition to aspirin, all patients continue receiving aspirin indefinitely. The primary efficacy end points of this study are the incidence of a composite end point including all cause deaths, myocardial infarction, the incidence of Academic Research Consortium defined definite or probable stent thrombosis and stroke (MACCE) at 24 months. The primary safety end point is the incidence of GUSTO moderate or severe bleeding.
Read the detailed description
The ISR-DAPT Study is a multicenter, randomized controlled trial that will enroll 1000 subjects treated with percutaneous coronary intervention (PCI) for in-stent restenosis. All patients will be randomized to receive either 12 months or 24 months of dual antiplatelet therapy with a P2Y12 receptor antagonist in addition to aspirin after index procedure. All patients continue receiving aspirin indefinitely. The primary efficacy end points of this study are the incidence of a composite end point including all cause deaths, myocardial infarction, the incidence of Academic Research Consortium defined definite or probable stent thrombosis and stroke (MACCE) at 24 months. The primary safety end point is the incidence of GUSTO moderate or severe bleeding at 24 months.
- Conditions
- Percutaneous Coronary Intervention
- Being tested
- 12 months of P2Y12 receptor antagonist, 24 months of P2Y12 receptor antagonist, Aspirin
- Keywords
- Dual Antiplatelet Treatment, In-Stent Restenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12 months of P2Y12 receptor antagonistDrug
All subjects will be received 12 months of dual antiplatelet therapy with a P2Y12 receptor antagonist (clopidogrel/prasugrel/ticagrelor) in addition to aspirin.
24 months of P2Y12 receptor antagonistDrug
All subjects will be received 24 months of dual antiplatelet therapy with a P2Y12 receptor antagonist (clopidogrel/prasugrel/ticagrelor) in addition to aspirin.
AspirinDrug
The maintenance dose of aspirin is 100 mg daily, to be taken indefinitely.
| Study group | Role | What they receive |
|---|---|---|
| 24 months of P2Y12 receptor antagonist | Active comparator | Receive 24 months of dual antiplatelet therapy (with a P2Y12 receptor antagonist in addition to aspirin) after index procedure. All subjects receive aspirin for the duration of study. Receives: Drug: 24 months of P2Y12 receptor antagonist; Drug: Aspirin |
| 12 months of P2Y12 receptor antagonist | Placebo comparator | Receive 12 months of dual antiplatelet therapy (with a P2Y12 receptor antagonist in addition to aspirin) after index procedure. All subjects receive aspirin for the duration of study. Receives: Drug: 12 months of P2Y12 receptor antagonist; Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACCE
Incidence of a composite end point including all cause deaths, myocardial infarction, the incidence of Academic Research Consortium defined definite or probable stent thrombosis and stroke (MACCE) at 24 months.
Measured: 24 months
Secondary outcomes (1)
Safety end point assessed by incidence of GUSTO moderate or severe bleeding.
Specifically, bleeding complications are classified as severe if they are intracerebral or if they result in substantial hemodynamic compromise requiring treatment. Moderate bleeding is defined by the need for transfusion.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startJan 2013
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yujie Zhou, Beijing Anzhen Hospital
- Investigators
- Yujie Zhou, MD, PhD, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02402491
- Sponsor's protocol ID
- ISR-DAPT
- Status last verified
- Mar 2015
- First submitted
- 23 Mar 2015
- Last updated
- 30 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Twelve Versus 24 Months of Dual Antiplatelet Therapy in Patients With Percutaneous Coronary Intervention for In-stent Restenosis
- ClinicalTrials.gov ID
- NCT02402491
- Acronym / sponsor ID
- ISR-DAPT
- Conditions
- Percutaneous Coronary Intervention
- Keywords
- Dual Antiplatelet Treatment, In-Stent Restenosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 30 Mar 2015 (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.
Patients undergoing the percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) are enrolled. All patients will be randomized to receive either 12 months or 24 months of dual antiplatelet therapy with a P2Y12 receptor antagonist in addition to aspirin, all patients continue receiving aspirin indefinitely. The primary efficacy end points of this study are the incidence of a composite end point including all cause deaths, myocardial infarction, the incidence of Academic Research Consortium defined definite or probable stent thrombosis and stroke (MACCE) at 24 months. The primary safety end point is the incidence of GUSTO moderate or severe bleeding.
Detailed description
The ISR-DAPT Study is a multicenter, randomized controlled trial that will enroll 1000 subjects treated with percutaneous coronary intervention (PCI) for in-stent restenosis. All patients will be randomized to receive either 12 months or 24 months of dual antiplatelet therapy with a P2Y12 receptor antagonist in addition to aspirin after index procedure. All patients continue receiving aspirin indefinitely. The primary efficacy end points of this study are the incidence of a composite end point including all cause deaths, myocardial infarction, the incidence of Academic Research Consortium defined definite or probable stent thrombosis and stroke (MACCE) at 24 months. The primary safety end point is the incidence of GUSTO moderate or severe bleeding at 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 24 months of P2Y12 receptor antagonist | Active comparator | Drug: 24 months of P2Y12 receptor antagonist, Drug: AspirinReceive 24 months of dual antiplatelet therapy (with a P2Y12 receptor antagonist in addition to aspirin) after index procedure. All subjects receive aspirin for the duration of study. |
| 12 months of P2Y12 receptor antagonist | Placebo comparator | Drug: 12 months of P2Y12 receptor antagonist, Drug: AspirinReceive 12 months of dual antiplatelet therapy (with a P2Y12 receptor antagonist in addition to aspirin) after index procedure. All subjects receive aspirin for the duration of study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects 18-80 years of age
- Undergoing percutaneous intervention with stent deployment for the treatment of in-stent restenosis
Key exclusion criteria (7 listed)
- Pregnant women
- Planned surgery necessitating discontinuation of antiplatelet therapy within the 24 months after enrollment
- Current medical condition with a life expectancy of <2 years
- Concurrent enrollment in another device or drug study whose protocol specifically rules out concurrent enrollment
- Subjects on warfarin or similar anticoagulant therapy
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 |
|---|---|---|
| 12 months of P2Y12 receptor antagonistAll subjects will be received 12 months of dual antiplatelet therapy with a P2Y12 receptor antagonist (clopidogrel/prasugrel/ticagrelor) in addition to aspirin. | Drug | 12 months of P2Y12 receptor antagonist |
| 24 months of P2Y12 receptor antagonistAll subjects will be received 24 months of dual antiplatelet therapy with a P2Y12 receptor antagonist (clopidogrel/prasugrel/ticagrelor) in addition to aspirin. | Drug | 24 months of P2Y12 receptor antagonist |
| AspirinThe maintenance dose of aspirin is 100 mg daily, to be taken indefinitely. | Drug | 12 months of P2Y12 receptor antagonist, 24 months of P2Y12 receptor antagonist |
Primary outcome
MACCE
Time frame: 24 months
Incidence of a composite end point including all cause deaths, myocardial infarction, the incidence of Academic Research Consortium defined definite or probable stent thrombosis and stroke (MACCE) at 24 months.
1 secondary outcome
Safety end point assessed by incidence of GUSTO moderate or severe bleeding.
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2015.
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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.
Yujie Zhou, MD, PhD principal investigator
Beijing Anzhen 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 12 months of P2Y12 receptor antagonist, 24 months of P2Y12 receptor antagonist and Aspirin in people with Percutaneous Coronary Intervention, run by Beijing Anzhen Hospital at 1 site in China.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 30 Mar 2015. 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 China. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
MACCE (time frame: 24 months). 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 30 Mar 2015.