Acute Ischemic StrokePhase 3NCT07162064
Heparin for RAO Post-Transradial Angiography in AIS
A Phase 3 study testing Heparin - Therapeutic dosage and Saline (0.9% NaCl) in people with Acute Ischemic Stroke, run by Xiang Luo at 1 site in China.
Trial summary
Cerebral angiography is a critical diagnostic tool in neurology, serving as the "gold standard" for evaluating cerebrovascular stenosis, hemodynamics, aneurysms, and arteriovenous malformations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Heparin - Therapeutic dosage and Saline (0.9% NaCl)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 440 participants
- Where
- 1 siteChina
- Study dates
- 4 Aug 2025to 4 Feb 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Active systemic bleeding
- Renal insufficiency (eGFR <30 mL/min or serum creatinine >200 μmol/L)
- Investigator-determined ineligibility for trial participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Safety of Heparinization for Radial Artery Occlusion After Transradial Cerebral Angiography in Patients With Acute Ischemic Stroke - A Multicenter, Prospective, Double-blind, Randomized Trail
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
- Being tested
- Heparin - Therapeutic dosage, Saline (0.9% NaCl)
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heparin - Therapeutic dosageDrug
Intra-arterial sheath injection of heparin 2500 units before operation
Saline (0.9% NaCl)Drug
Intra-arterial sheath injection of 2mL saline (0.9% sodium chloride)
| Study group | Role | What they receive |
|---|---|---|
| Heparin Group | Experimental | Inject 2,500 units (2mL) of unfractionated heparin intra-arterially via sheath prior to angiography Receives: Drug: Heparin - Therapeutic dosage |
| Saline (0.9% NaCl) | Placebo comparator | Inject 2ml saline intra-arterially via sheath prior to angiography Receives: Drug: Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hours radial artery occlusion rate after operation
Radial artery occlusion rate was assessed by ultrasonography 24 hours±12hours after the procedure.
Measured: 24 hours±12hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start4 Aug 2025
- Primary completion31 Jan 2026
- Study completion4 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiang Luo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiang Luo, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07162064
- Sponsor's protocol ID
- 2025-S021
- Status last verified
- Mar 2026
- First submitted
- 26 Aug 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20466199Snelling 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.
PubMed 29311120
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Heparinization for Radial Artery Occlusion After Transradial Cerebral Angiography in Patients With Acute Ischemic Stroke - A Multicenter, Prospective, Double-blind, Randomized Trail
- ClinicalTrials.gov ID
- NCT07162064
- Acronym / sponsor ID
- 2025-S021
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Xiang LuoUniversity, hospital or other
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 4 Feb 2026 (actual)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heparin Group | Experimental | Drug: Heparin - Therapeutic dosageInject 2,500 units (2mL) of unfractionated heparin intra-arterially via sheath prior to angiography |
| Saline (0.9% NaCl) | Placebo comparator | Drug: Saline (0.9% NaCl)Inject 2ml saline intra-arterially via sheath prior to angiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heparin - Therapeutic dosageIntra-arterial sheath injection of heparin 2500 units before operation | Drug | Heparin Group |
| Saline (0.9% NaCl)Intra-arterial sheath injection of 2mL saline (0.9% sodium chloride) | Drug | Saline (0.9% NaCl) |
Primary outcome
24 hours radial artery occlusion rate after operation
Time frame: 24 hours±12hours
Radial artery occlusion rate was assessed by ultrasonography 24 hours±12hours after the procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Results publication: PubMed 20466199Rao 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.
- Results publication: PubMed 29311120Snelling 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Heparin - Therapeutic dosage and Saline (0.9% NaCl) in people with Acute Ischemic Stroke, run by Xiang Luo at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 hours radial artery occlusion rate after operation (time frame: 24 hours±12hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07162064, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.