Dual Antiplatelet Therapy (DAPT) in Patients With Baseline Thrombocytopenia

Recruiting

• Conditions: Baseline Thrombocytopenia

• Registration Number: NCT06223607
• Lead Sponsor: Methodist Health System

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).

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

Study Timeline

• Study Start: 2022-08-22
• Study First Submitted: 2023-11-13
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-16
• Last Update Submitted: 2024-01-16
• Study First Posted: 2024-01-25
• Last Update Posted: 2024-01-25
• Primary Completion: 2024-08-22
• Study Completion: 2024-08-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of bleeding	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 Outcome Measures

Name	Time	Method
Incidence of ischemic events	1 year	number of ischemic events
All-cause mortality	1 year	all-cause mortality in patients with chronic thrombocytopenia maintained on DAPT with clopidogrel compared to patients maintained on DAPT with ticagrelor.
Duration of DAPT	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.

Trial Locations

Locations (1)

Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States