NCT06223607

Brief Summary

The use of clopidogrel as part of DAPT will be associated with lower bleeding rates compared to ticagrelor in patients with chronic thrombocytopenia requiring Percutaneous intervention (PCI )with Drug Eluting Stent (DES) or Bare Metal Stint(BMS).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
17mo left

Started Aug 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress74%
Aug 2022Dec 2027

Study Start

First participant enrolled

August 22, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2026

Expected
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2027

Last Updated

June 10, 2026

Status Verified

January 1, 2026

Enrollment Period

4.4 years

First QC Date

November 13, 2023

Last Update Submit

June 8, 2026

Conditions

Baseline Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

  • Incidence of bleeding

    To evaluate the difference in bleeding rates in patients with chronic thrombocytopenia maintained on DAPT with clopidogrel compared to patients maintained on DAPT with ticagrelor.

    1 year

Secondary Outcomes (3)

  • Incidence of ischemic events

    1 year

  • All-cause mortality

    1 year

  • Duration of DAPT

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study population of 18 years of age ,PCI with either DES or BMS during study time period (April 1, 2018 through July 1 2021) ,Thrombocytopenia on at least one occasion prior to PCI and at least one dose of DAPT post-PCI with aspirin and either clopidogrel or ticagrelor

You may qualify if:

  • ≥ 18 years
  • PCI with either DES or BMS during study time period (April 1, 2018 through July 1 2021)
  • Thrombocytopenia defined as platelet count \<100 x103 /µL on at least one occasion prior to PCI
  • At least one dose of DAPT post-PCI with aspirin and either clopidogrel or ticagrelor

You may not qualify if:

  • Death within 48 hours post-PCI
  • DAPT prior to cardiac catheterization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

RECRUITING

Study Officials

  • Jessica Rago Crotty, Pharm D

    Methodist Midlothian Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bethany Brauer

CONTACT

214-947-4681mhsirb@mhd.com

Colette Ngo Ndjom

CONTACT

214-947-1289mhsirb@mhd.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2023

First Posted

January 25, 2024

Study Start

August 22, 2022

Primary Completion (Estimated)

December 28, 2026

Study Completion (Estimated)

December 22, 2027

Last Updated

June 10, 2026

Record last verified: 2026-01

Locations

US(1)