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Recruiting NCT06223607

Dual Antiplatelet Therapy (DAPT) in Patients With Baseline Thrombocytopenia

Observational Baseline Thrombocytopenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Baseline Thrombocytopenia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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).

Detailed description

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

Primary outcome measures

  • Incidence of bleeding [Time frame: 1 year]
Secondary outcome measures (3)
  • Incidence of ischemic events [Time frame: 1 year]
  • All-cause mortality [Time frame: 1 year]
  • Duration of DAPT [Time frame: 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

United States · 1 center
  • Methodist Dallas Medical Center — Dallas

Identifiers

NCT: NCT06223607 · 036.PHA.2022.D

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗