NCT02413268

Brief Summary

A randomized comparison of topical nitroglycerin versus placebo gel for prevention of radial artery occlusion after transradial catheterization.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,400

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2016

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 9, 2015

Completed
11 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

4.3 years

First QC Date

April 6, 2015

Last Update Submit

September 14, 2019

Conditions

Total Atherosclerotic Occlusion of Radial Artery

Outcome Measures

Primary Outcomes (1)

  • Radial Artery Occlusion

    up to 2 hours

Secondary Outcomes (2)

  • Headache

    up to 4 hours

  • Hypotension

    up to 4 hours

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Patient receives an antibiotic ointment with no vasoactive drug as a placebo for comparison.

Drug: Nitroglycerin

Nitropaste

ACTIVE COMPARATOR

Nitroglycerin 2% ointment is applied above the compression surface on the skin, to evaluate its efficacy in reducing radial artery occlusion.

Drug: Nitroglycerin

Interventions

NitroglycerinDRUG
Also known as: Nitropaste
NitropastePlacebo

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • : Absence of informed consent. 2: Known allergy to nitroglycerin. 3: Ad-hoc PCI 4: Previous ipsilateral TRA. 5: Warfarin or NOAC therapy. 6: Systolic blood pressure \< 100 mmHg. 7: Critical aortic stenosis (AVA \< 0.6 sq.cm) 8: Inability to administer unfractionated heparin. 9: Need for post-procedural use of heparin (UFH, LMWH) 10: Raynaud's disease. 11: Sheathless technique or use of \> 11 cm sheath. 12: History of intractable headache of any cause OR Migraine headache.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Apex Heart Institute

Ahmedabad, Gujarat, India

RECRUITING

MeSH Terms

Interventions

Nitroglycerin

Intervention Hierarchy (Ancestors)

Nitro CompoundsOrganic Chemicals

Study Officials

  • Tejas M Patel, MD

    Apex Heart Institute, Ahmedabad, India

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tejas M Patel, MD

CONTACT

theheartworld@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman

Study Record Dates

First Submitted

April 6, 2015

First Posted

April 9, 2015

Study Start

March 1, 2016

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

September 17, 2019

Record last verified: 2019-09

Locations

IN(1)