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Clinical Trials/TCTR20211024003
TCTR20211024003
Recruiting
Phase 3

Outcomes of 1-month vs 3-month dual antiplatelet therapy in high bleeding risk patients after percutaneous coronary intervention, a randomized controlled trial

Faculty of Medicine, Chiang Mai University0 sites502 target enrollmentOctober 24, 2021
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Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
Faculty of Medicine, Chiang Mai University
Enrollment
502
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 24, 2021
End Date
January 7, 2023
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\.All subjects age more than 18 years of age
  • •2\.diagnosis of acute coronary syndrome (STEMI or NSTEMI) who are acceptable candidates for treatment with a DES.
  • •3\.The subjects must meet pre\-defined ARC\-HBR criteria for being high\-bleeding risk and are candidates for 1\-month DAPT. Patients are considered to be at HBR if at least 1 major or 2 minor criteria are met

Exclusion Criteria

  • •1\.Pregnant and breastfeeding women
  • •2\.Atrial fibrillation
  • •3\.Subjects requiring a planned PCI procedure after 1 month of index procedure
  • •4\.Procedure planned to require stand\-alone POBA, or stand\-alone atherectomy
  • •5\.Active bleeding at the time of inclusion
  • •6\.Cardiogenic shock
  • •7\.Subject with planned surgery or procedure necessitating discontinuation of DAPT within one month following index procedure
  • •8\.Subject not expected to comply with long\-term single antiplatelet therapy.
  • •9\.A known hypersensitivity or contraindication to aspirin, heparin, P2Y12 inhibitors, mTOR inhibiting drugs such as zotarolimus, biolimus A9 (or its derivatives), cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings, stainless steel (or other metal ions found in 316L stainless steel), zinc, or a sensitivity to contrast media, which cannot be adequately pre\- medicated.
  • •10\.PCI during the previous 6 months for a lesion other than the target lesion of the index procedure

Outcomes

Primary Outcomes

Not specified

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