Heparin for RAO Post-Transradial Angiography in AIS

NCT07162064 | Completed Phase 3 DMC

• 1 other identifier: 2025-S021
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

Brief Summary

Cerebral angiography is a critical diagnostic tool in neurology, serving as the "gold standard" for evaluating cerebrovascular stenosis, hemodynamics, aneurysms, and arteriovenous malformations. Compared to the traditional transfemoral approach, transradial cerebral angiography (TRA) offers advantages such as preserved patient privacy, immediate post-procedure mobility, shorter hospitalization, and fewer access-site complications. Consequently, TRA has gained increasing acceptance among patients and clinicians as the preferred vascular access . However, radial artery occlusion (RAO) remains a common complication post-TRA, with reported incidence rates varying widely (1%-33%). RAO is particularly concerning as the radial artery serves as a key access for both cardiac and neurovascular interventions; its occlusion limits future procedural options.Evidence from interventional cardiology suggests that intra-arterial heparin administration significantly reduces RAO risk.However, patients undergoing transradial cerebral angiography are predominantly those with cerebrovascular diseases, including acute ischemic stroke (AIS)-a population at potential risk for hemorrhagic transformation.Although the 2022 Chinese Expert Consensus on Neurointerventional Diagnosis and Treatment via Transradial Access recommends intra-sheath heparin injection to prevent RAO, this recommendation is largely extrapolated from coronary intervention data. While several studies indicate that low-dose heparin is safe in moderate-to-severe AIS patients without increasing intracranial hemorrhage risk , high-level evidence specific to neurointerventional procedures-particularly in AIS patients-remains lacking.This multicenter, double-blind, randomized controlled trial (RCT) aims to: Evaluate the efficacy of intra-arterial heparin in preventing RAO following TRA cerebral angiography.Assess the safety of heparin in AIS patients, with a focus on hemorrhagic complications. By addressing these questions, the study will provide evidence-based guidance to optimize TRA outcomes, balancing RAO prevention with bleeding risk in neurovascular interventions. Its findings hold significant clinical value for improving the safety and efficacy of transradial cerebral angiography.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 24 hours radial artery occlusion rate after operation

  Radial artery occlusion rate was assessed by ultrasonography 24 hours±12hours after the procedure.

  24 hours±12hours

Study Arms (2)

Heparin Group

EXPERIMENTAL

Inject 2,500 units (2mL) of unfractionated heparin intra-arterially via sheath prior to angiography

Drug: Heparin - Therapeutic dosage

Saline (0.9% NaCl)

PLACEBO COMPARATOR

Inject 2ml saline intra-arterially via sheath prior to angiography

Drug: Saline (0.9% NaCl)

Interventions

Heparin - Therapeutic dosage DRUG

Intra-arterial sheath injection of heparin 2500 units before operation

Heparin Group

Saline (0.9% NaCl) DRUG

Intra-arterial sheath injection of 2mL saline (0.9% sodium chloride)

Saline (0.9% NaCl)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Acute ischemic stroke onset within 7 days (inclusive)
• Patients undergoing cerebral angiography via transradial approach
• Participant or legal representative capable of providing informed consent

You may not qualify if:

• Current anticoagulation therapy prior to procedure
• Positive modified Allen's test result
• History of coronary artery bypass grafting(CABG) with missing right radial artery graft
• Severe forearm deformities (skin/musculoskeletal) or failed radial artery sheath placement
• Suspected/confirmed pregnancy or lactation
• Acute ischemic stroke with hemorrhagic transformation
• Active systemic bleeding
• Renal insufficiency (eGFR \<30 mL/min or serum creatinine \>200 μmol/L)
• Investigator-determined ineligibility for trial participation

Sponsors & Collaborators

• Xiang Luo: lead

Study Sites (1)

Tongji Hospital

Wuhan, China

Location

Related Publications (2)

• Rao SV, Cohen MG, Kandzari DE, Bertrand OF, Gilchrist IC. The transradial approach to percutaneous coronary intervention: historical perspective, current concepts, and future directions. J Am Coll Cardiol. 2010 May 18;55(20):2187-95. doi: 10.1016/j.jacc.2010.01.039.

  PMID: 20466199 RESULT

• Snelling BM, Sur S, Shah SS, Khandelwal P, Caplan J, Haniff R, Starke RM, Yavagal DR, Peterson EC. Transradial cerebral angiography: techniques and outcomes. J Neurointerv Surg. 2018 Sep;10(9):874-881. doi: 10.1136/neurintsurg-2017-013584. Epub 2018 Jan 8.

  PMID: 29311120 RESULT

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 9, 2025
• Study Start: August 4, 2025
• Primary Completion: January 31, 2026
• Study Completion: February 4, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)