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Not yet recruitingNCT04501900SPARTAUpdated Aug 6, 2020

The 3 Years vs 1 Year DAPT After XINSORB BRS Implantation

A Phase 4 interventional study of Clopidogrel in Cardiovascular Diseases, sponsored by Shanghai Zhongshan Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-06.

Sponsored by Shanghai Zhongshan Hospital · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 6 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 4
Study type
Interventional
Enrollment
2,106
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cardiovascular Diseases
03

In context

Cardiovascular Diseases

4,902 studies on the registry are indexed under Cardiovascular Diseases; 920 are open to participants now.

This study's planned enrollment of 2,106 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,106 participants (estimated)

Study arms

  • Active comparator
    prolonged DAPT group

    Drug: Clopidogrel

  • No intervention
    standard DAPT group

Interventions

  • DrugClopidogrel

    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.

06

What researchers measure

Primary outcomes

  1. MACE

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

    Time frame: 3 years

  2. BARC type 3, 4, and 5 bleeding events

    Time frame: 3 years

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04501900
Lead sponsor
Shanghai Zhongshan Hospital
Responsible party
Sponsor
First posted
Aug 6, 2020
Start date
Oct 2020 (estimated)
Primary completion
Apr 2024 (estimated)
Completion
Apr 2026 (estimated)
Last update
Aug 6, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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