Mobilization of Endothelial Progenitor Cells and Aspirin (TROPHIC 3)
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ClinicalTrials.gov Identifier: NCT02674958 |
Recruitment Status :
Recruiting
First Posted : February 5, 2016
Last Update Posted : June 21, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertrophic Obstructive Cardiomyopathy | Drug: Aspirin | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Basic Science |
Official Title: | Mobilization of Endothelial Progenitor Cells Following Alcohol Septal Ablation in Hypertrophic Obstructive Cardiomyopathy: Randomized Controlled Trial of Aspirin |
Actual Study Start Date : | May 2016 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | December 2022 |

Arm | Intervention/treatment |
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Active Comparator: Aspirin
Aspirin 325mg orally bolus followed by 162mg orally daily during alcohol septal ablation for hypertrophic obstructive cardiomyopathy until day 7.
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Drug: Aspirin
Aspirin 325mg bolus followed by 162mg daily until day 7 post alcohol septal ablation
Other Name: Acetylsalicylic acid |
No Intervention: No aspirin
No aspirin allowed during alcohol septal ablation for hypertrophic obstructive cardiomyopathy until day 7.
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- Maximum circulating endothelial progenitor cells as a ratio to baseline at any timepoint [ Time Frame: 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
- Endothelial cell migration in vitro compared to baseline at any timepoint [ Time Frame: 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
- Peak SDF-1 level [ Time Frame: 0 hour, 1 hour, 6 hours, 24 hours, 72 hours and 7 days ]Change in level of SDF-1 at 0, 1, 6, 24, 72 hours and on day 7 post procedure
- Peak angiopoietin-1 level [ Time Frame: 0 hour, 1 hour, 6 hours, 24 hours 72 hours and 7 days ]Change in level of angiopoietin-1 at 0, 1, 6, 24, 72 hours and day 7 post procedure
- Peak angiopoietin-2 level [ Time Frame: 0 hour, 1 hour, 6 hours, 24 hours 72 hours and 7 days ]Change in level of angiopoietin-2 at 0, 1, 6, 24, 72 hours and on day 7 post procedure
- Peak tie-2 level [ Time Frame: 0 hour, 1 hour, 6 hours, 24 hours 72 hours and 7 days ]Change in level of tie-2 at 0, 1, 6, 24, 72 hours and on day 7 post procedure
- Peak vascular endothelial growth factor (VEGF) level [ Time Frame: 0 hour, 1 hour, 6 hours, 24 hours 72 hours and 7 days ]Change in level of VEGF at 0, 1, 6, 24, 72 hours and on day 7 post procedure

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients who have been selected to undergo alcohol septal ablation for hypertrophic obstructive cardiomyopathy based on clinical need
- Age >18 years, <80 years
Exclusion Criteria:
- Patients with known allergy to aspirin
- Inability or refusal to consent to participate in the study
- Patients who are on non-steroidal anti-inflammatory drugs and cannot be stopped for the duration of the study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02674958
Contact: Aun-Yeong Chong, MD, MRCP | +1 613 696 7280 | achong@ottawaheart.ca | |
Contact: Christopher Glover, MD, FRCPC | +1 613 696 7327 | cglover@ottawaheart.ca |
Canada, Ontario | |
University of Ottawa Heart Institute | Recruiting |
Ottawa, Ontario, Canada, K1Y 4W7 | |
Contact: Poppy MacPhee +1 613 6967000 ext 14646 pmacphee@ottawaheart.ca |
Principal Investigator: | Aun-Yeong Chong, MD, MRCP | OHIRC |
Responsible Party: | Ottawa Heart Institute Research Corporation |
ClinicalTrials.gov Identifier: | NCT02674958 |
Other Study ID Numbers: |
20150432 |
First Posted: | February 5, 2016 Key Record Dates |
Last Update Posted: | June 21, 2019 |
Last Verified: | June 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
endothelial progenitor cells aspirin acetylsalicylic acid alcohol septal ablation |
Cardiomyopathies Cardiomyopathy, Hypertrophic Hypertrophy Heart Diseases Cardiovascular Diseases Pathological Conditions, Anatomical Aortic Stenosis, Subvalvular Aortic Valve Stenosis Heart Valve Diseases Aspirin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics |