The 3 Years vs 1 Year DAPT After XINSORB BRS Implantation

Cardiovascular Diseases Clinical Trial

— SPARTA  

Official title:

The Standard Versus Prolonged Dual Antiplatelet Therapy After the XINSORB Bioresorbable Scaffold Implantation Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04501900
• Other study ID #: ZS20200804
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: October 2020
• Est. completion date: April 2026

Study information

• Verified date: August 2020
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2106
• Est. completion date: April 2026
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACE	The incidence of a composite endpoint, including all-cause death, any myocardial infarction (MI), and all revascularization	3 years
Primary	BARC type 3, 4, and 5 bleeding events		3 years