Mobilization of Endothelial Progenitor Cells and Aspirin (TROPHIC 3)

January 12, 2023 updated by: Ottawa Heart Institute Research Corporation

Mobilization of Endothelial Progenitor Cells Following Alcohol Septal Ablation in Hypertrophic Obstructive Cardiomyopathy: Randomized Controlled Trial of Aspirin

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

6

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
        • University of Ottawa Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • Acetylsalicylic acid
No Intervention: No aspirin
No aspirin allowed during alcohol septal ablation for hypertrophic obstructive cardiomyopathy until day 7.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0 hour, 1 hour, 6 hours, 24 hours, 72 hours and 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0 hour, 1 hour, 6 hours, 24 hours, 72 hours and 7 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0 hour, 1 hour, 6 hours, 24 hours, 72 hours and 7 days
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
0 hour, 1 hour, 6 hours, 24 hours 72 hours and 7 days
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
0 hour, 1 hour, 6 hours, 24 hours 72 hours and 7 days
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
0 hour, 1 hour, 6 hours, 24 hours 72 hours and 7 days
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
0 hour, 1 hour, 6 hours, 24 hours 72 hours and 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Heart Institute Research Corporation

Investigators

  • Principal Investigator: Aun-Yeong Chong, MD, MRCP, OHIRC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

April 1, 2022

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

January 6, 2016

First Submitted That Met QC Criteria

February 2, 2016

First Posted (Estimate)

February 5, 2016

Study Record Updates

Last Update Posted (Estimate)

January 16, 2023

Last Update Submitted That Met QC Criteria

January 12, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20150432

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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