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Mono- Versus Dual antiPlatelet Therapy During 6-12 Months After New Generation Drug Eluting Stent Implantation

NCT03198741 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 783

Last updated 2022-05-19

No results posted yet for this study

Summary

Long-term DAPT is recommended after percutaneous coronary intervention (PCI) in patients with coronary artery disease. However, antiplatelet therapy may have adverse consequences, the most common of which is gastrointestinal mucosal injury with ulceration and bleeding. The extent to which an an abbreviated DAPT strategy reduces gastrointestinal mucosal injury has not been studied, principally due to the lack of sensitive, noninvasive measurements capable of detecting gastrointestinal injury.ANKON® magnetically controlled capsule endoscopy (AMCE) is a non-invasive, active controlled system which affords assessment of the stomach and entire small intestine.The current randomized study will assess gastrointestinal mucosal injury and bleeding via AMCE in patients on three different antiplatelet regimens and establish a gastrointestinal mucosal injury scoring system which may prove useful in guiding optimal antiplatelet agent usage after PCI.

Conditions

  • Gastrointestinal Injury
  • Ischemic Heart Disease

Interventions

DRUG

Aspirin + clopidogrel

After randomization(6 months±2 weeks after enrollment),receive aspirin 100mg/d + clopidogrel 75mg/d for an additional 6 months. The above treatments between 6 and 12 months are double-blinded.

DRUG

Clopidogrel monotherapy

After randomization(6 months±2 weeks after enrollment),receive clopidogrel 75mg/d + placebo (clopidogrel monotherapy group) for an additional 6 months. The above treatments between 6 and 12 months are double-blinded.

DRUG

Aspirin monotherapy

After randomization(6 months±2 weeks after enrollment),receive aspirin 100mg/d + placebo (aspirin monotherapy group) for an additional 6 months. The above treatments between 6 and 12 months are double-blinded.

Sponsors & Collaborators

  • Changhai Hospital

    collaborator OTHER

  • ANKON medical technologies (Shanghai)Co.,LTD

    collaborator UNKNOWN

  • Shenyang Northern Hospital

    lead OTHER

Principal Investigators

  • Yaling Han, PhD · General Hospital of Shenyang Military Region

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-13
Primary Completion
2020-08-13
Completion
2020-08-13

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03198741 on ClinicalTrials.gov