Mobilization of Endothelial Progenitor Cells and Aspirin

Phase 3

Terminated

• Conditions: Hypertrophic Obstructive Cardiomyopathy
• Interventions: Drug: Aspirin

• Registration Number: NCT02674958
• Lead Sponsor: Ottawa Heart Institute Research Corporation

Brief Summary

Aspirin at doses used during acute myocardial infarction may inhibit the mobilization of endothelial progenitor cells (EPCs).

Detailed Description

Aspirin has been shown to lower the number of EPCs in a time- and concentration-dependent manner. In vitro studies also show that aspirin may reduce the migratory and adhesive capacity of isolated EPCs, inhibit iNOS and tubule formation, which are pre-requisites for angiogenesis. This is relevant when patients are given a loading dose of 325mg at the time of diagnosis of acute myocardial infarction where higher numbers of EPCs have been associated with better outcomes. Furthermore, in the PLATO (Platelet Inhibition and Patient Outcomes) trial, high dose aspirin appeared to counteract the beneficial effect seen when ticagrelor or clopidogrel was used with low doses of aspirin in acute coronary syndromes (ACS).

As aspirin is currently standard of care in the management of ACS, it is difficult to conduct a study of the effect of aspirin versus placebo in that scenario. However, during alcohol septal ablation for hypertrophic obstructive cardiomyopathy, the indication for an antiplatelet agent is not well defined and varies between operators. When a small amount of myocardium is deliberately destroyed in this process, it serves as an ideal model to study the effect of aspirin on the biology of EPCs in vivo. This could provide an explanation to the different effects of high versus low dose aspirin when combined with a second antiplatelet agent in the management of ACS.

Study Timeline

• Study First Submitted: 2016-01-06
• Study First Submitted QC: 2016-02-02
• Study First Posted: 2016-02-05
• Study Start: 2016-05
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-12
• Last Update Posted: 2023-01-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

1. Patients who have been selected to undergo alcohol septal ablation for hypertrophic obstructive cardiomyopathy based on clinical need
2. Age >18 years, <80 years

Exclusion Criteria

1. Patients with known allergy to aspirin
2. Inability or refusal to consent to participate in the study
3. Patients who are on non-steroidal anti-inflammatory drugs and cannot be stopped for the duration of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aspirin	Aspirin	Aspirin 325mg orally bolus followed by 162mg orally daily during alcohol septal ablation for hypertrophic obstructive cardiomyopathy until day 7.

Primary Outcome Measures

Name	Time	Method
Maximum circulating endothelial progenitor cells as a ratio to baseline at any timepoint	0 hour, 1 hour, 6 hours, 24 hours, 72 hours and 7 days	Change in number of EPCs measured at 0 (baseline), 1, 6, 24, 72 hours and on day 7 post procedure

Secondary Outcome Measures

Name	Time	Method
Endothelial cell migration in vitro compared to baseline at any timepoint	0 hour, 1 hour, 6 hours, 24 hours, 72 hours and 7 days	Change in endothelial migration measured at 0,1, 6, 24, 72 hours and on day 7 post procedure

Trial Locations

Locations (1)

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada