The 3 Years vs 1 Year DAPT After XINSORB BRS Implantation (SPARTA)

August 5, 2020 updated by: Shanghai Zhongshan Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

2106

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: prolonged DAPT group
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.
NO_INTERVENTION: standard DAPT group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE
Time Frame: 3 years
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
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 1, 2020

Primary Completion (ANTICIPATED)

April 1, 2024

Study Completion (ANTICIPATED)

April 1, 2026

Study Registration Dates

First Submitted

August 4, 2020

First Submitted That Met QC Criteria

August 5, 2020

First Posted (ACTUAL)

August 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 6, 2020

Last Update Submitted That Met QC Criteria

August 5, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZS20200804

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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