Dual Antiplatelet Therapy (DAPT) in Patients With Baseline Thrombocytopenia

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06223607

Enrollment

300

Registered

2024-01-25

Start date

2022-08-22

Completion date

2027-12-22

Last updated

2026-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Baseline Thrombocytopenia

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

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Contacts

CONTACTBethany Brauer

mhsirb@mhd.com214-947-4681

CONTACTColette Ngo Ndjom

mhsirb@mhd.com214-947-1289

PRINCIPAL_INVESTIGATORJessica Rago Crotty, Pharm D

Methodist Midlothian Medical Center

Outcome results