Clinical trial NCT01489917: A-priori Versus Provisional Heparin on Radial Artery Occlusion After Transradial Coronary Angiography and Patent Hemostasis
Official title: Comparison of A-priori Versus Provisional Heparin Therapy on Radial Artery Occlusion After Transradial Coronary Angiography and Patent Hemostasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: radial artery occlusion
hemostasis
coronary intervention
radial approach
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Community Medical Center, Scranton, PA
name: Sheth Vadilal Sarabhai General Hospital
First posted: 2011-12-12
Enrollment: 428
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The Provisional Heparin TherApy on Radial Artery Occlusion after transradial coronary angiography and patent Hemostasis (PHARAOH) study compares the strategy of standard a-priori heparin use in patients undergoing transradial coronary angiography to a strategy of provisional heparin administration only if patent hemostasis is not achievable.

Detailed description: Transradial access use for coronary angiography and intervention is increasing. Its efficacy in lowering access site complications, as well as increased patient comfort, has been proven unequivocally. One of the complications of transradial access is radial artery occlusion (RAO) that occurs with a variable incidence. It is population specific, with a higher prevalence in subsets, such as women, and patient's with small radial arteries. RAO is also known to be higher at hospital discharge and radial recanalization may spontaneously occur at later times. It is usually asymptomatic. Its main adverse impact is by limiting future transradial access from that radial artery. Since most of the patient's with atherosclerotic vascular disease may undergo several invasive procedures during their lifetime, prevention of RAO is of paramount importance.

Heparinization, during the procedure, has been shown to be of benefit in lowering the incidence of RAO. Maintaining patency of the radial artery during hemostasis, has also been shown to be effective in prevention of RAO following transradial access. As maintenance of flow has potent antithrombotic effect, it is unclear whether systemic anticoagulation is still required in all cases.

In some cases, it would be preferable to avoid heparin administration prior to coronary angiography. It is currently unknown whether it would be safe to refrain from heparin administration in case of transradial catheterization and patent hemostasis technique.

Eligibility criteria: Inclusion Criteria:

* all diagnostic cardiac cath patients

Exclusion Criteria:

* warfarin therapy
* previous ipsilateral TRA
* lack of consent
* abnormal (type D) Barbeau test
* scleroderma
* thrombocytopenia
* or other contraindications to heparin

Primary outcomes:
measure: Radial artery occlusion
timeFrame: At 30 days after the cathlab procedure
Secondary outcomes:
measure: Radial artery occlusion
timeFrame: At 24 hours after the cathlab procedure
Other outcomes:
Locations:
city: Scranton
country: United States
facility: Commonwealth Medical College,
state: Pennsylvania
city: Quebec City
country: Canada
facility: IUCPQ
state: Quebec
city: Ahmedabad
country: India
facility: Sheth VS General Hospital,
Study officials:
affiliation: TCMC, Scranton (PA, USA)
name: Samir B. Pancholy, MD
role: PRINCIPAL_INVESTIGATOR
References: