NCT02674958

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2016

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 5, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

January 17, 2023

Status Verified

January 1, 2023

Enrollment Period

5.9 years

First QC Date

January 6, 2016

Last Update Submit

January 12, 2023

Conditions

Hypertrophic Obstructive Cardiomyopathy

Keywords

endothelial progenitor cellsaspirinacetylsalicylic acidalcohol septal ablation

Outcome Measures

Primary Outcomes (1)

  • Maximum circulating endothelial progenitor cells as a ratio to baseline at any timepoint

    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 Outcomes (1)

  • Endothelial cell migration in vitro compared to baseline at any timepoint

    0 hour, 1 hour, 6 hours, 24 hours, 72 hours and 7 days

Other Outcomes (5)

  • Peak SDF-1 level

    0 hour, 1 hour, 6 hours, 24 hours, 72 hours and 7 days

  • Peak angiopoietin-1 level

    0 hour, 1 hour, 6 hours, 24 hours 72 hours and 7 days

  • Peak angiopoietin-2 level

    0 hour, 1 hour, 6 hours, 24 hours 72 hours and 7 days

  • +2 more other outcomes

Study Arms (2)

Aspirin

ACTIVE COMPARATOR

Aspirin 325mg orally bolus followed by 162mg orally daily during alcohol septal ablation for hypertrophic obstructive cardiomyopathy until day 7.

Drug: Aspirin

No aspirin

NO INTERVENTION

No aspirin allowed during alcohol septal ablation for hypertrophic obstructive cardiomyopathy until day 7.

Interventions

AspirinDRUG

Aspirin 325mg bolus followed by 162mg daily until day 7 post alcohol septal ablation

Also known as: Acetylsalicylic acid
Aspirin

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have been selected to undergo alcohol septal ablation for hypertrophic obstructive cardiomyopathy based on clinical need
  • Age \>18 years, \<80 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Related Publications (3)

  • Chen TG, Chen JZ, Xie XD. Effects of aspirin on number, activity and inducible nitric oxide synthase of endothelial progenitor cells from peripheral blood. Acta Pharmacol Sin. 2006 Apr;27(4):430-6. doi: 10.1111/j.1745-7254.2006.00298.x.

    PMID: 16539843RESULT

  • Lou J, Povsic TJ, Allen JD, Adams SD, Myles S, Starr AZ, Ortel TL, Becker RC. The effect of aspirin on endothelial progenitor cell biology: preliminary investigation of novel properties. Thromb Res. 2010 Sep;126(3):e175-9. doi: 10.1016/j.thromres.2009.11.017. Epub 2010 Jul 24.

    PMID: 20659762RESULT

  • Etulain J, Fondevila C, Negrotto S, Schattner M. Platelet-mediated angiogenesis is independent of VEGF and fully inhibited by aspirin. Br J Pharmacol. 2013 Sep;170(2):255-65. doi: 10.1111/bph.12250.

    PMID: 23713888RESULT

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Interventions

Aspirin

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Aun-Yeong Chong, MD, MRCP

    OHIRC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2016

First Posted

February 5, 2016

Study Start

May 1, 2016

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

January 17, 2023

Record last verified: 2023-01

Locations

CA(1)