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NCT Number: NCT06223607

Dual Antiplatelet Therapy (DAPT) in Patients With Baseline Thrombocytopenia

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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location status: Recruiting

Location contact

Bethany Brauer

CONTACT

[email protected]

214-947-4681 ext. 74681

Colette Ngo Ndjom

CONTACT

[email protected]

214-947-4681 ext. 71289

Jessica Rago Crotty, Pharm D

PRINCIPAL_INVESTIGATOR

About this study

Patients with thrombocytopenia are at an increased risk of both bleeding and ischemic events following PCI; however, there is a paucity of data on how to optimally manage these risks. Data indicates that ticagrelor is associated with reduced ischemic outcomes with an accompanying increased risk of bleed in the broader population. This study will assess P2Y12 agent selection in patients with chronic thrombocytopenia to determine if one better balances risks of ischemic and bleeding events following coronary intervention

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Incidence of bleeding

    Time frame: 1 year

    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.

Secondary outcomes

  1. Incidence of ischemic events

    Time frame: 1 year

    number of ischemic events

  2. All-cause mortality

    Time frame: 1 year

    all-cause mortality in patients with chronic thrombocytopenia maintained on DAPT with clopidogrel compared to patients maintained on DAPT with ticagrelor.

  3. Duration of DAPT

    Time frame: 1 year

    To evaluate the difference in rate of ischemic events and all-cause mortality in patients with chronic thrombocytopenia maintained on DAPT with clopidogrel compared to patients maintained on DAPT with ticagrelor.

Study contacts

Contact information is provided by the study sponsor or research team.

Bethany Brauer

CONTACT

[email protected]

214-947-4681 ext. 74681

Colette Ngo Ndjom

CONTACT

[email protected]

214-947-1289 ext. 71289

Sponsors and collaborators

Lead sponsor

Methodist Health System

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jan 25, 2024
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.