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

This study is currently recruiting participants.
Verified March 2017 by Dr. Tejas M. Patel, MD, Total Cardiovascular Solutions
Sponsor:
ClinicalTrials.gov Identifier:
NCT02413268
First Posted: April 9, 2015
Last Update Posted: March 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Tejas M. Patel, MD, Total Cardiovascular Solutions
  Purpose
A randomized comparison of topical nitroglycerin versus placebo gel for prevention of radial artery occlusion after transradial catheterization.

Condition Intervention Phase
Total Atherosclerotic Occlusion of Radial Artery Drug: Nitroglycerin Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Dr. Tejas M. Patel, MD, Total Cardiovascular Solutions:

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

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

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


Estimated Enrollment: 2400
Study Start Date: March 2016
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: April 6, 2015
First Posted: April 9, 2015
Last Update Posted: March 14, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Nitroglycerin
Vasodilator Agents