Ischemic StrokePhase 4PATH-ICASNCT06243133
Pair Antiplatelet THerapy in Ischemic Stroke With Intracranial Artery Stenosis
A Phase 4 study testing clopidogrel for 90 days combined with aspirin for 90 days and clopidogrel for 30 days combined with aspirin for 90 days in people with Ischemic Stroke and Intracranial Arteriosclerosis, run by Sichuan Provincial People's Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn about efficacy and safety of dual antiplatelet therapy in ischemic stroke with intracranial artery stenosis. The main question it aims to answer are: whether aspirin combined with clopidogrel for 3 month is better than 1 months for patients with non-cardiogenic cerebral… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Ischemic Stroke, Intracranial Arteriosclerosis, Secondary Prevention
- What is being tested?
- clopidogrel for 90 days combined with aspirin for 90 days and clopidogrel for 30 days combined with aspirin for 90 days
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 31 Mar 2026
- Phase
- Phase 4
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40 ~ 80 years old;
- Patients diagnosed as non-cardiogenic cerebral infarction according to the WHO definition of stroke, with MRA/CTA/DSA confirmed intracranial artery stenosis ≥50% (intracranial carotid artery, M1 and proximal M2 segment of middle cerebral artery, A1 and A2 segment of anterior cerebral artery, P1 and P2 segment of posterior cerebral artery, intracranial vertebral artery and basilar artery);
- First stroke onset within 7 days;
- NIHSS score ≤5;
- Patients or family members sign informed consent forms;
Who cannot join
- Patients receiving thrombolysis or endovascular therapy;
- Patients with recurrent stroke;
- Patients has undergone major surgery or major trauma within the past 30 days;
- History of gastrointestinal bleeding, active peptic ulcer, intracranial hemorrhage or other hemorrhagic diseases;
- Contraindications or intolerances to the use of antiplatelet therapeutics;
- Platelet count <100*109/L, hemoglobin<110g/L;
Show all 9Show fewer
- Patients with severe organ insufficiency or other serious disease (e.g., severe cardiopulmonary failure, advanced tumor, severe dementia);
- Patients intolerant to MRI scan are replaced by CT or DSA;
- poor compliance, unable to meet the requirements of the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Sichuan Provincial People's Hospital
Chengdu, Sichuan
Jie Yang, doctor, +86 13678130516, yangjie1126@163.com
About this study
The goal of this clinical trial is to learn about efficacy and safety of dual antiplatelet therapy in ischemic stroke with intracranial artery stenosis. The main question it aims to answer are:
whether aspirin combined with clopidogrel for 3 month is better than 1 months for patients with non-cardiogenic cerebral infarction with intracranial artery stenosis.
Read more
Participants will get dual antiplatelet therapy (aspirin plus clopidogrel) for 1 month or 3 months within 7 days of the first stroke.
Researchers will compare experimental group (3 months dual antiplatelet therapy) with comparison group (1 month dual antiplatelet therapy), to see if experimental group would reduce stroke recurrence or mortality, and increase bleeding and other adverse prognosis.
- Being tested
- clopidogrel for 90 days combined with aspirin for 90 days, clopidogrel for 30 days combined with aspirin for 90 days
- Medical subject headings
- Ischemic Stroke, Intracranial Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clopidogrel for 90 days combined with aspirin for 90 daysDrug
Clopidogrel 300mg on the first day, then 75mg/day for 90 consecutive days; Aspirin 100mg/day for 90 days
clopidogrel for 30 days combined with aspirin for 90 daysDrug
Clopidogrel 300mg on the first day, then 75mg/ day for 30 consecutive days; Aspirin 100mg/ day for 90 days
| Study group | Role | What they receive |
|---|---|---|
| Dual antiplatelet therapy for 30 days | Experimental | Clopidogrel 300mg on the first day, then 75mg/ day for 30 consecutive days; Aspirin 100mg/ day for 90 days Receives: Drug: clopidogrel for 30 days combined with aspirin for 90 days |
| Dual antiplatelet therapy for 90 days | Active comparator | Clopidogrel 300mg on the first day, then 75mg/day for 90 consecutive days; Aspirin 100mg/day for 90 days Receives: Drug: clopidogrel for 90 days combined with aspirin for 90 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-month major ischemic events and major bleeding events
Including any of the following: Cardiovascular and cerebrovascular mortality, Incidence of stroke (including ischemic and hemorrhagic), Incidence of myocardial infarction, bleeding events classified by BARC (Bleeding Academic Research Consortium) criteria
Measured: 3-month
Secondary outcomes (2)
disability
mRS(Modified Rankin Scale)>2
Measured: 3-month
Cardiovascular or cerebrovascular mortality
mortality of Cardiovascular or cerebrovascular disease
Measured: 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start1 Jul 2024 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nengwei Yu, Sichuan Provincial People's Hospital
- Investigators
- Nengwei Yu, master, Study chair, Sichuan Provincial People's HospitalJie Yang, doctor, Study chair, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243133
- Sponsor's protocol ID
- 20223972
- Acronym
- PATH-ICAS
- Status last verified
- Jun 2024
- First submitted
- 28 Jan 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu S, Wu B, Liu M, Chen Z, Wang W, Anderson CS, Sandercock P, Wang Y, Huang Y, Cui L, Pu C, Jia J, Zhang T, Liu X, Zhang S, Xie P, Fan D, Ji X, Wong KL, Wang L; China Stroke Study Collaboration. Stroke in China: advances and challenges in epidemiology, prevention, and management. Lancet Neurol. 2019 Apr;18(4):394-405. doi: 10.1016/S1474-4422(18)30500-3.
PubMed 30878104GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1545-1602. doi: 10.1016/S0140-6736(16)31678-6.
PubMed 27733282Wang Y, Zhao X, Liu L, Soo YO, Pu Y, Pan Y, Wang Y, Zou X, Leung TW, Cai Y, Bai Q, Wu Y, Wang C, Pan X, Luo B, Wong KS; CICAS Study Group. Prevalence and outcomes of symptomatic intracranial large artery stenoses and occlusions in China: the Chinese Intracranial Atherosclerosis (CICAS) Study. Stroke. 2014 Mar;45(3):663-9. doi: 10.1161/STROKEAHA.113.003508. Epub 2014 Jan 30.
PubMed 24481975Wong KS, Chen C, Fu J, Chang HM, Suwanwela NC, Huang YN, Han Z, Tan KS, Ratanakorn D, Chollate P, Zhao Y, Koh A, Hao Q, Markus HS; CLAIR study investigators. Clopidogrel plus aspirin versus aspirin alone for reducing embolisation in patients with acute symptomatic cerebral or carotid artery stenosis (CLAIR study): a randomised, open-label, blinded-endpoint trial. Lancet Neurol. 2010 May;9(5):489-97. doi: 10.1016/S1474-4422(10)70060-0. Epub 2010 Mar 22.
PubMed 20335070Valgimigli M, Frigoli E, Heg D, Tijssen J, Juni P, Vranckx P, Ozaki Y, Morice MC, Chevalier B, Onuma Y, Windecker S, Tonino PAL, Roffi M, Lesiak M, Mahfoud F, Bartunek J, Hildick-Smith D, Colombo A, Stankovic G, Iniguez A, Schultz C, Kornowski R, Ong PJL, Alasnag M, Rodriguez AE, Moschovitis A, Laanmets P, Donahue M, Leonardi S, Smits PC; MASTER DAPT Investigators. Dual Antiplatelet Therapy after PCI in Patients at High Bleeding Risk. N Engl J Med. 2021 Oct 28;385(18):1643-1655. doi: 10.1056/NEJMoa2108749. Epub 2021 Aug 28.
PubMed 34449185Wang Y, Wang Y, Zhao X, Liu L, Wang D, Wang C, Wang C, Li H, Meng X, Cui L, Jia J, Dong Q, Xu A, Zeng J, Li Y, Wang Z, Xia H, Johnston SC; CHANCE Investigators. Clopidogrel with aspirin in acute minor stroke or transient ischemic attack. N Engl J Med. 2013 Jul 4;369(1):11-9. doi: 10.1056/NEJMoa1215340. Epub 2013 Jun 26.
PubMed 23803136Johnston SC, Easton JD, Farrant M, Barsan W, Conwit RA, Elm JJ, Kim AS, Lindblad AS, Palesch YY; Clinical Research Collaboration, Neurological Emergencies Treatment Trials Network, and the POINT Investigators. Clopidogrel and Aspirin in Acute Ischemic Stroke and High-Risk TIA. N Engl J Med. 2018 Jul 19;379(3):215-225. doi: 10.1056/NEJMoa1800410. Epub 2018 May 16.
PubMed 29766750
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pair Antiplatelet THerapy in Ischemic Stroke With Intracranial Artery Stenosis
- ClinicalTrials.gov ID
- NCT06243133
- Acronym / sponsor ID
- PATH-ICAS / 20223972
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 6 Feb 2024 (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.
The goal of this clinical trial is to learn about efficacy and safety of dual antiplatelet therapy in ischemic stroke with intracranial artery stenosis. The main question it aims to answer are:
whether aspirin combined with clopidogrel for 3 month is better than 1 months for patients with non-cardiogenic cerebral infarction with intracranial artery stenosis.
Participants will get dual antiplatelet therapy (aspirin plus clopidogrel) for 1 month or 3 months within 7 days of the first stroke.
Researchers will compare experimental group (3 months dual antiplatelet therapy) with comparison group (1 month dual antiplatelet therapy), to see if experimental group would reduce stroke recurrence or mortality, and increase bleeding and other adverse prognosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual antiplatelet therapy for 30 days | Experimental | Drug: clopidogrel for 30 days combined with aspirin for 90 daysClopidogrel 300mg on the first day, then 75mg/ day for 30 consecutive days; Aspirin 100mg/ day for 90 days |
| Dual antiplatelet therapy for 90 days | Active comparator | Drug: clopidogrel for 90 days combined with aspirin for 90 daysClopidogrel 300mg on the first day, then 75mg/day for 90 consecutive days; Aspirin 100mg/day for 90 days |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 40 ~ 80 years old;
- Patients diagnosed as non-cardiogenic cerebral infarction according to the WHO definition of stroke, with MRA/CTA/DSA confirmed intracranial artery stenosis ≥50% (intracranial carotid artery, M1 and proximal M2 segment of middle cerebral artery, A1 and A2 segment of anterior cerebral artery, P1 and P2 segment of posterior cerebral artery, intracranial vertebral artery and basilar artery);
- First stroke onset within 7 days;
- NIHSS score ≤5;
- Patients or family members sign informed consent forms;
Key exclusion criteria (9 listed)
- Patients receiving thrombolysis or endovascular therapy;
- Patients with recurrent stroke;
- Patients has undergone major surgery or major trauma within the past 30 days;
- History of gastrointestinal bleeding, active peptic ulcer, intracranial hemorrhage or other hemorrhagic diseases;
- Contraindications or intolerances to the use of antiplatelet therapeutics;
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 |
|---|---|---|
| clopidogrel for 90 days combined with aspirin for 90 daysClopidogrel 300mg on the first day, then 75mg/day for 90 consecutive days; Aspirin 100mg/day for 90 days | Drug | Dual antiplatelet therapy for 90 days |
| clopidogrel for 30 days combined with aspirin for 90 daysClopidogrel 300mg on the first day, then 75mg/ day for 30 consecutive days; Aspirin 100mg/ day for 90 days | Drug | Dual antiplatelet therapy for 30 days |
Primary outcome
3-month major ischemic events and major bleeding events
Time frame: 3-month
Including any of the following: Cardiovascular and cerebrovascular mortality, Incidence of stroke (including ischemic and hemorrhagic), Incidence of myocardial infarction, bleeding events classified by BARC (Bleeding Academic Research Consortium) criteria
2 secondary outcomes
disability
Time frame: 3-month
Cardiovascular or cerebrovascular mortality
Time frame: 3-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Background: PubMed 30878104Wu S, Wu B, Liu M, Chen Z, Wang W, Anderson CS, Sandercock P, Wang Y, Huang Y, Cui L, Pu C, Jia J, Zhang T, Liu X, Zhang S, Xie P, Fan D, Ji X, Wong KL, Wang L; China Stroke Study Collaboration. Stroke in China: advances and challenges in epidemiology, prevention, and management. Lancet Neurol. 2019 Apr;18(4):394-405. doi: 10.1016/S1474-4422(18)30500-3.
- Background: PubMed 27733282GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1545-1602. doi: 10.1016/S0140-6736(16)31678-6.
- Background: PubMed 24481975Wang Y, Zhao X, Liu L, Soo YO, Pu Y, Pan Y, Wang Y, Zou X, Leung TW, Cai Y, Bai Q, Wu Y, Wang C, Pan X, Luo B, Wong KS; CICAS Study Group. Prevalence and outcomes of symptomatic intracranial large artery stenoses and occlusions in China: the Chinese Intracranial Atherosclerosis (CICAS) Study. Stroke. 2014 Mar;45(3):663-9. doi: 10.1161/STROKEAHA.113.003508. Epub 2014 Jan 30.
- Background: PubMed 20335070Wong KS, Chen C, Fu J, Chang HM, Suwanwela NC, Huang YN, Han Z, Tan KS, Ratanakorn D, Chollate P, Zhao Y, Koh A, Hao Q, Markus HS; CLAIR study investigators. Clopidogrel plus aspirin versus aspirin alone for reducing embolisation in patients with acute symptomatic cerebral or carotid artery stenosis (CLAIR study): a randomised, open-label, blinded-endpoint trial. Lancet Neurol. 2010 May;9(5):489-97. doi: 10.1016/S1474-4422(10)70060-0. Epub 2010 Mar 22.
- Background: PubMed 34449185Valgimigli M, Frigoli E, Heg D, Tijssen J, Juni P, Vranckx P, Ozaki Y, Morice MC, Chevalier B, Onuma Y, Windecker S, Tonino PAL, Roffi M, Lesiak M, Mahfoud F, Bartunek J, Hildick-Smith D, Colombo A, Stankovic G, Iniguez A, Schultz C, Kornowski R, Ong PJL, Alasnag M, Rodriguez AE, Moschovitis A, Laanmets P, Donahue M, Leonardi S, Smits PC; MASTER DAPT Investigators. Dual Antiplatelet Therapy after PCI in Patients at High Bleeding Risk. N Engl J Med. 2021 Oct 28;385(18):1643-1655. doi: 10.1056/NEJMoa2108749. Epub 2021 Aug 28.
- Background: PubMed 23803136Wang Y, Wang Y, Zhao X, Liu L, Wang D, Wang C, Wang C, Li H, Meng X, Cui L, Jia J, Dong Q, Xu A, Zeng J, Li Y, Wang Z, Xia H, Johnston SC; CHANCE Investigators. Clopidogrel with aspirin in acute minor stroke or transient ischemic attack. N Engl J Med. 2013 Jul 4;369(1):11-9. doi: 10.1056/NEJMoa1215340. Epub 2013 Jun 26.
- Background: PubMed 29766750Johnston SC, Easton JD, Farrant M, Barsan W, Conwit RA, Elm JJ, Kim AS, Lindblad AS, Palesch YY; Clinical Research Collaboration, Neurological Emergencies Treatment Trials Network, and the POINT Investigators. Clopidogrel and Aspirin in Acute Ischemic Stroke and High-Risk TIA. N Engl J Med. 2018 Jul 19;379(3):215-225. doi: 10.1056/NEJMoa1800410. Epub 2018 May 16.
- Individual participant dataSharing planned: No
Related trials for Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic
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.
Nengwei Yu, master study chair
Sichuan Provincial People's Hospital
Jie Yang, doctor study chair
Sichuan Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing clopidogrel for 90 days combined with aspirin for 90 days and clopidogrel for 30 days combined with aspirin for 90 days in people with Ischemic Stroke and Intracranial Arteriosclerosis, run by Sichuan Provincial People's Hospital 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 5 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: status not confirmed, as of the sponsor's last update on 18 Jun 2024. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Yang, doctor (+86 13678130516, yangjie1126@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-month major ischemic events and major bleeding events (time frame: 3-month). 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 NCT06243133, which also lists 7 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 18 Jun 2024.