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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 : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation

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

Condition or disease Intervention/treatment Phase
Hypertrophic Obstructive Cardiomyopathy Drug: Aspirin Phase 3

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.


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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
Study Start Date : May 2016
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : September 2020


Arm Intervention/treatment
Active Comparator: Aspirin
Aspirin 325mg orally bolus followed by 162mg orally daily during alcohol septal ablation for hypertrophic obstructive cardiomyopathy until day 7.
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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
Criteria

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

Information from the National Library of Medicine

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


Contacts
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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

Locations
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Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Colleen Chilton    +1 613 6967000 ext 14646    cchilton@ottawaheart.ca   
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
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Principal Investigator: Aun-Yeong Chong, MD, MRCP OHIRC

Publications of Results:
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Responsible Party: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT02674958     History of Changes
Other Study ID Numbers: 20150432
First Posted: February 5, 2016    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Ottawa Heart Institute Research Corporation:
endothelial progenitor cells
aspirin
acetylsalicylic acid
alcohol septal ablation

Additional relevant MeSH terms:
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Aspirin
Cardiomyopathies
Hypertrophy
Cardiomyopathy, Hypertrophic
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics