Mobilization of Endothelial Progenitor Cells and Aspirin (TROPHIC 3)

University of Ottawa Heart Institute

Status and phase: Terminated; Phase 3

Conditions: Hypertrophic Obstructive Cardiomyopathy

Treatments: Drug: Aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT02674958

20150432

Details and patient eligibility

About

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

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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6 participants in 2 patient groups

Aspirin

Active Comparator group

Description:

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

Treatment:

Drug: Aspirin

No aspirin

No Intervention group

Description:

No aspirin allowed during alcohol septal ablation for hypertrophic obstructive cardiomyopathy until day 7.