The 3 Years vs 1 Year DAPT After XINSORB BRS Implantation

NCT04501900 | Not Yet Recruiting Phase 4

• 1 other identifier: ZS20200804
• Study Type: interventional
• Target: 2,106
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• MACE

  The incidence of a composite endpoint, including all-cause death, any myocardial infarction (MI), and all revascularization

  3 years

• BARC type 3, 4, and 5 bleeding events

  3 years

Study Arms (2)

prolonged DAPT group

ACTIVE COMPARATOR

Drug: Clopidogrel

standard DAPT group

NO INTERVENTION

Interventions

Clopidogrel 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.

prolonged DAPT group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Related Publications (1)

• 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.

  PMID: 36670441 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Clopidogrel

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 6, 2020
• Study Start: October 1, 2020
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2026
• Last Updated: August 6, 2020

Record last verified: 2020-08