Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mobilization of Endothelial Progenitor Cells and Aspirin (TROPHIC 3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02674958
Recruitment Status : Recruiting
First Posted : February 5, 2016
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy
Drug Information available for: Aspirin

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location contacts
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
Layout table for location information
Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Poppy MacPhee    +1 613 6967000 ext 14646    pmacphee@ottawaheart.ca   
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
Layout table for investigator information
Principal Investigator: Aun-Yeong Chong, MD, MRCP OHIRC
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
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
Keywords provided by Ottawa Heart Institute Research Corporation:
endothelial progenitor cells
aspirin
acetylsalicylic acid
alcohol septal ablation
Additional relevant MeSH terms:
Layout table for MeSH terms
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