Cardiovascular DiseasesPhase 4SPARTANCT04501900
The 3 Years vs 1 Year DAPT After XINSORB BRS Implantation
A Phase 4 study testing Clopidogrel in people with Cardiovascular Diseases, run by Shanghai Zhongshan Hospital.
Trial summary
The aim of the SPARTA trial is to clarify the impact of extending DAPT beyond 1 year after XINSORB BRS implantation by investigating the balance of risk and benefit in a broad population of treated patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,106 participants
- Where
- No sites listed yet
- Study dates
- Oct 2020to Apr 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with XINSORB BRS implantation, then treated with DAPT for 12 months
- Written informed consent from the subjects
- Qualified candidates for coronary bypass surgery
- Lesions with reference vessel diameter 2.75 to 3.5 mm
Who cannot join
- Age ≤ 18 years
- Cardiogenetic shock
- Chronic heart failure with a left ventricular ejection fraction ≤ 30%
- Oral anticoagulation therapy
- Known allergy or intolerance to the study medications
- Malignancies and other comorbid conditions with a life expectancy less than 5 years
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- Subjects treated with both BRS and DES during the index procedure
- Pregnant wowen
- Planned staged PCI
- Contemporaneous enrollment in a different clinical trial
- Any revascularization within 1 year
- Planned surgery necessitating discontinuation of antiplatelet therapy within 36 months after enrollment
- Unprotected left main artery
- Lesions located at the ostium of the main coronary artery
- bifurcation lesions (Medina 1,1,1) planning to be treated with two stents strategy
About this study
Official title: The Standard Versus Prolonged Dual Antiplatelet Therapy After the XINSORB Bioresorbable Scaffold Implantation Trial
The aim of the SPARTA trial is to clarify the impact of extending DAPT beyond 1 year after XINSORB BRS implantation by investigating the balance of risk and benefit in a broad population of treated patients.
- Conditions
- Cardiovascular Diseases
- Being tested
- Clopidogrel
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
Study subjects diagnosed as stable, unstable ischemic coronary disease or myocardial infarction planning to undergo percutaneous coronary intervention (PCI) and no contradiction to prolonged DAPT are eligible for this trial. All subjects will provide written informed consent to participate. Subjects will be enrolled into the study before or within 24 hours after the index procedure. Subjects will be randomized to either discontinue P2Y12 inhibitor (clopidogrel or ticagrelor) (12 months total) or receive P2Y12 inhibitor for an additional 24 months (36 months total). Aspirin will be maintained in the entire study and can be replaced by cilostazol or indobufen if subjects are intolerant. Dosage of antiplatelet drugs will be according to local standard of practice. Subjects will be treated with XINSORB BRS only.
| Study group | Role | What they receive |
|---|---|---|
| prolonged DAPT group | Active comparator | Not described Receives: Drug: Clopidogrel |
| standard DAPT group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
The incidence of a composite endpoint, including all-cause death, any myocardial infarction (MI), and all revascularization
Measured: 3 years
BARC type 3, 4, and 5 bleeding events
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study startOct 2020 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionApr 2026 (estimated)
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 Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- 2,106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04501900
- Sponsor's protocol ID
- ZS20200804
- Acronym
- SPARTA
- Status last verified
- Aug 2020
- First submitted
- 4 Aug 2020
- Last updated
- 6 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wu Y, Yin J, Li C, Zhang W, Shen L, Ge L, Qian J, Ge J. The standard versus prolonged dual antiplatelet therapy after the XINSORB bioresorbable scaffold implantation (SPARTA) trial: study protocol for a randomized controlled trial. Trials. 2023 Jan 20;24(1):49. doi: 10.1186/s13063-022-07028-8.
PubMed 36670441
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Standard Versus Prolonged Dual Antiplatelet Therapy After the XINSORB Bioresorbable Scaffold Implantation Trial
- ClinicalTrials.gov ID
- NCT04501900
- Acronym / sponsor ID
- SPARTA / ZS20200804
- Conditions
- Cardiovascular Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,106 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 6 Aug 2020 (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.
The aim of the SPARTA trial is to clarify the impact of extending DAPT beyond 1 year after XINSORB BRS implantation by investigating the balance of risk and benefit in a broad population of treated patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prolonged DAPT group | Active comparator | Drug: Clopidogrel |
| standard DAPT group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with XINSORB BRS implantation, then treated with DAPT for 12 months
- Written informed consent from the subjects
- Qualified candidates for coronary bypass surgery
- Lesions with reference vessel diameter 2.75 to 3.5 mm
Key exclusion criteria (15 listed)
- Age ≤ 18 years
- Cardiogenetic shock
- Chronic heart failure with a left ventricular ejection fraction ≤ 30%
- Oral anticoagulation therapy
- Known allergy or intolerance to the study medications
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 |
|---|---|---|
| ClopidogrelStudy subjects diagnosed as stable, unstable ischemic coronary disease or myocardial infarction planning to undergo percutaneous coronary intervention (PCI) and no contradiction to prolonged DAPT are eligible for this trial. All subjects will provide written informed consent to participate. Subjects will be enrolled into the study before or within 24 hours after the index procedure. Subjects will be randomized to either discontinue P2Y12 inhibitor (clopidogrel or ticagrelor) (12 months total) or receive P2Y12 inhibitor for an additional 24 months (36 months total). Aspirin will be maintained in the entire study and can be replaced by cilostazol or indobufen if subjects are intolerant. Dosage of antiplatelet drugs will be according to local standard of practice. Subjects will be treated with XINSORB BRS only. | Drug | prolonged DAPT group |
Primary outcome
MACE
Time frame: 3 years
The incidence of a composite endpoint, including all-cause death, any myocardial infarction (MI), and all revascularization
BARC type 3, 4, and 5 bleeding events
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Derived from this study: PubMed 36670441Wu Y, Yin J, Li C, Zhang W, Shen L, Ge L, Qian J, Ge J. The standard versus prolonged dual antiplatelet therapy after the XINSORB bioresorbable scaffold implantation (SPARTA) trial: study protocol for a randomized controlled trial. Trials. 2023 Jan 20;24(1):49. doi: 10.1186/s13063-022-07028-8.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clopidogrel in people with Cardiovascular Diseases, run by Shanghai Zhongshan Hospital.
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 4 inclusion and 15 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 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
MACE (time frame: 3 years). The study lists 2 primary outcomes in all. 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 NCT04501900, 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 6 Aug 2020.