NCT04374799

Brief Summary

Patients undergoing cardiac catheterization will be randomized to 3 groups: no anticoagulant, low dose anticoagulant and high dose anticoagulant.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,623

participants targeted

Target at P75+ for phase_3

Timeline
7mo left

Started Oct 2020

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Study Progress91%
Oct 2020Dec 2026

First Submitted

Initial submission to the registry

April 30, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 5, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

October 5, 2020

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 20, 2026

Status Verified

August 1, 2025

Enrollment Period

5.8 years

First QC Date

April 30, 2020

Last Update Submit

February 18, 2026

Conditions

Cardiac Disease

Outcome Measures

Primary Outcomes (1)

  • radial artery occlusion

    by ultrasound

    1 hour

Secondary Outcomes (6)

  • Hematoma> 5 cm

    one hour post procedure

  • access site bleeding

    1 hour

  • non access site bleeding

    1 day

  • access site complications

    1 day

  • wrist band duration

    3 hours

  • +1 more secondary outcomes

Study Arms (3)

Low dose heparin

ACTIVE COMPARATOR

heparin (25 IU/Kg -maximal dose 3,000 IU)

Drug: Heparin

High dose heparin

ACTIVE COMPARATOR

heparin 50 IU/kg -maximal dose 5,000 IU

Drug: Heparin

Placebo

PLACEBO COMPARATOR

Normal saline 0.9%.

Drug: Placebos

Interventions

HeparinDRUG

two doses of heparin

High dose heparinLow dose heparin
PlacebosDRUG

placebo

Placebo

Eligibility Criteria

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

You may qualify if:

  • diagnostic cardiac catheterization; Small size sheath; patency of the ulno-palmar circulation

You may not qualify if:

  • abnormal ulno-palmar circulation; Prior radial artery thrombosis; Prior surgery close to the access site; Emergent cardiac catheterization; History of HIT or allergy to heparin; Patients requiring anticoagulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hamilton Health Sciences

Hamilton, Ontario, Canada

RECRUITING

London Health Sciences Centre

London, Ontario, N6A5A5, Canada

RECRUITING

MeSH Terms

Conditions

Heart Diseases

Interventions

Heparin

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Central Study Contacts

Shahar Lavi, MD

CONTACT

519-6633611Shahar.lavi@lhsc.on.ca

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2020

First Posted

May 5, 2020

Study Start

October 5, 2020

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 20, 2026

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)