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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 : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation

Tracking Information
First Submitted Date  ICMJE January 6, 2016
First Posted Date  ICMJE February 5, 2016
Last Update Posted Date June 21, 2019
Actual Study Start Date  ICMJE May 2016
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02674958 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2016)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 2, 2016)
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Mobilization of Endothelial Progenitor Cells and Aspirin
Official Title  ICMJE Mobilization of Endothelial Progenitor Cells Following Alcohol Septal Ablation in Hypertrophic Obstructive Cardiomyopathy: Randomized Controlled Trial of Aspirin
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Hypertrophic Obstructive Cardiomyopathy
Intervention  ICMJE Drug: Aspirin
Aspirin 325mg bolus followed by 162mg daily until day 7 post alcohol septal ablation
Other Name: Acetylsalicylic acid
Study Arms  ICMJE
  • Active Comparator: Aspirin
    Aspirin 325mg orally bolus followed by 162mg orally daily during alcohol septal ablation for hypertrophic obstructive cardiomyopathy until day 7.
    Intervention: Drug: Aspirin
  • No Intervention: No aspirin
    No aspirin allowed during alcohol septal ablation for hypertrophic obstructive cardiomyopathy until day 7.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 2, 2016)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02674958
Other Study ID Numbers  ICMJE 20150432
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Ottawa Heart Institute Research Corporation
Study Sponsor  ICMJE Ottawa Heart Institute Research Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Aun-Yeong Chong, MD, MRCP OHIRC
PRS Account Ottawa Heart Institute Research Corporation
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP