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Topical Nitroglycerin To Prevent Radial Artery Occlusion After Transradial Access: NTP-RAO Trial (NTP-RAO)

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ClinicalTrials.gov Identifier: NCT02413268
Recruitment Status : Recruiting
First Posted : April 9, 2015
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
A randomized comparison of topical nitroglycerin versus placebo gel for prevention of radial artery occlusion after transradial catheterization.

Condition or disease Intervention/treatment Phase
Total Atherosclerotic Occlusion of Radial Artery Drug: Nitroglycerin Phase 3

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Topical Nitroglycerin To Prevent Radial Artery Occlusion After Transradial Access: NTP-RAO Trial
Study Start Date : March 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Placebo
Patient receives an antibiotic ointment with no vasoactive drug as a placebo for comparison.
Drug: Nitroglycerin
Other Name: Nitropaste
Active Comparator: Nitropaste
Nitroglycerin 2% ointment is applied above the compression surface on the skin, to evaluate its efficacy in reducing radial artery occlusion.
Drug: Nitroglycerin
Other Name: Nitropaste


Outcome Measures

Primary Outcome Measures :
  1. Radial Artery Occlusion [ Time Frame: up to 2 hours ]

Secondary Outcome Measures :
  1. Headache [ Time Frame: up to 4 hours ]
    Pain in the head that is new-onset

  2. Hypotension [ Time Frame: up to 4 hours ]
    Systolic blood pressure < 90 mmHg that is new-onset


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Patients referred for cardiac catheterization.

Exclusion Criteria:

  • 1: 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02413268


Contacts
Contact: Tejas M Patel, MD theheartworld@gmail.com

Locations
India
Apex Heart Institute Recruiting
Ahmedabad, Gujarat, India
Contact: Tejas M Patel, MD       theheartworld@gmail.com   
Contact: Yash Soni       theheartworld@gmail.com   
Sponsors and Collaborators
Total Cardiovascular Solutions
Investigators
Principal Investigator: Tejas M Patel, MD Apex Heart Institute, Ahmedabad, India
More Information

Responsible Party: Dr. Tejas M. Patel, MD, Chairman, Total Cardiovascular Solutions
ClinicalTrials.gov Identifier: NCT02413268     History of Changes
Other Study ID Numbers: NTP1
First Posted: April 9, 2015    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Nitroglycerin
Vasodilator Agents