The 3 Years vs 1 Year DAPT After XINSORB BRS Implantation

NCT ID: NCT04501900

Last Updated: 2020-08-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 2106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-31
• Study Completion Date: 2026-04-30

Brief 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.

Conditions

Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

prolonged DAPT group

Group Type: ACTIVE_COMPARATOR

Clopidogrel

Intervention Type: DRUG

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.

standard DAPT group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Clopidogrel

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Subjects with XINSORB BRS implantation, then treated with DAPT for 12 months

2. Written informed consent from the subjects

3. Qualified candidates for coronary bypass surgery

4. Lesions with reference vessel diameter 2.75 to 3.5 mm

Exclusion Criteria

1. Age ≤ 18 years

2. Cardiogenetic shock

3. Chronic heart failure with a left ventricular ejection fraction ≤ 30%

4. Oral anticoagulation therapy

5. Known allergy or intolerance to the study medications

6. Malignancies and other comorbid conditions with a life expectancy less than 5 years

7. Subjects treated with both BRS and DES during the index procedure

8. Pregnant wowen

9. Planned staged PCI

10. Contemporaneous enrollment in a different clinical trial

11. Any revascularization within 1 year

12. Planned surgery necessitating discontinuation of antiplatelet therapy within 36 months after enrollment

13. Unprotected left main artery

14. Lesions located at the ostium of the main coronary artery

15. bifurcation lesions (Medina 1,1,1) planning to be treated with two stents strategy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 36670441 (View on PubMed)

Other Identifiers

ZS20200804

Identifier Type: -

Identifier Source: org_study_id