Antithrombotic Therapy With Regulation of Blood Pressure in Non-Cardioembolic Progressive Stroke

NCT06551727 | Enrolling By Invitation

• 1 other identifier: 2024213
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke has become the leading cause of death in China, with acute ischemic stroke still progressing within one week of onset, known as progressive ischemic stroke (PIS), which has a high rate of disability and mortality, accounting for 23-43% of the incidence of stroke. Non-cardioembolic PIS is one of the common types, and the current treatment mainly focuses on antithrombotic therapy, but the therapeutic effect is not satisfactory. More and more evidence suggests that hypotension is an unfavorable factor for PIS, so this study intends to explore the efficacy and safety of antithrombotic therapy with regulation of blood pressure in non-cardioembolic PIS.

Conditions

Stroke, Ischemic

Outcome Measures

Primary Outcomes (1)

• percentage of patients with an excellent outcome（mRS score 0-1）at 90 days after randomization

  modified Rankin scale (mRS，an ordinal global disability scale with scores ranging from 0 \[no symptoms\] to 6 \[death\]) at 90 days after randomization. An excellent outcome is defined as score of 0 or 1 on the mRS score at 90 days.

  at 90 days after randomization

Secondary Outcomes (10)

• proportion of patients with outcome measured by the Barthel index (BI)

  at 90 days after randomization

• proportion of patients with outcome measured by mRS

  at 90 days after randomization

• proportion of patients with an excellent outcome

  at 2 weeks after randomization and at day 30 after randomization

• proportion of patients with functional independence

  at 2 weeks after randomization and at day 30 after randomization

• proportion of patients with outcome measured by NIHSS

  at 2 weeks after randomization

Study Arms (2)

Control group

ACTIVE COMPARATOR

After stroke progression, all patients receive dual antiplatelet therapy (aspirin 100mg/day combined with clopidogrel 75mg/day) for the first 21 days, except in cases of cerebral hemorrhage. After this period, they continue to take aspirin 100mg/day orally for the long term.

Other: Control group

Intervention group

EXPERIMENTAL

After stroke progression, all patients receive dual antiplatelet therapy (aspirin 100mg/day combined with clopidogrel 75mg/day) for the first 21 days, except in cases of cerebral hemorrhage. After this period, they continue to take aspirin 100mg/day orally for the long term. In terms of blood pressure control, medications such as dopamine, metaraminol, or midodrine are used to achieve a systolic blood pressure target range of 160-180 mmHg within 1 h of random assignment and to maintain this target for 7 days (or death, should this event occur earlier). BP measurements are routinely captured using automated devices fitted to the unaffected arm, following the protocol recommended by the standard guideline. The readings are taken at 15-minute intervals for the initial hour, hourly from the first to the sixth hour, every six hours from 6 to 24 hours, and then twice daily for 7 days (or death, if earlier). Subsequently, these data are uploaded into the research database.

Other: Intervention group

Interventions

Intervention group OTHER

After stroke progression, all patients receive dual antiplatelet therapy (aspirin 100mg/day combined with clopidogrel 75mg/day) for the first 21 days, except in cases of cerebral hemorrhage. After this period, they continue to take aspirin 100mg/day orally for the long term. In terms of blood pressure control, medications such as dopamine, metaraminol, or midodrine are used to achieve a systolic blood pressure target range of 160-180 mmHg within 1 h of random assignment and to maintain this target for 7 days (or death, should this event occur earlier). BP measurements are routinely captured using automated devices fitted to the unaffected arm, following the protocol recommended by the standard guideline. The readings are taken at 15-minute intervals for the initial hour, hourly from the first to the sixth hour, every six hours from 6 to 24 hours, and then twice daily for 7 days (or death, if earlier). Subsequently, these data are uploaded into the research database.

Intervention group

Control group OTHER

After stroke progression, all patients receive dual antiplatelet therapy (aspirin 100mg/day combined with clopidogrel 75mg/day) for the first 21 days, except in cases of cerebral hemorrhage. After this period, they continue to take aspirin 100mg/day orally for the long term.

Control group

Eligibility Criteria

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

You may qualify if:

• Adults (aged ≥18 years) with an AIS who have been able to complete usual activities in daily life without support before the stroke;
• One of the following PIS manifestations:
• Within 7 days of onset, when symptom worsens and there are new lesions or infarct growth on DWI within 24 hours of aggravation, the National Institutes of Health Stroke Scale (NIHSS) score increases by ≥ 2 points ;
• Within 24 hours after IVT, when symptom worsens and there are new lesions or infarct growth on DWI within 24 hours of aggravation, the NIHSS score increases by ≥ 4 points compared to the baseline;
• Within 3h of stroke progression, ≥2 successive measurements of systolic blood pressure (SBP) \< 160 mm Hg for \>10 min.
• Computed tomographic angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA) confirms patients without visible large or medium-sized intracranial vessel occlusion.

You may not qualify if:

• After stroke progression, a head CT confirmed new cerebral hemorrhage or hemorrhagic transformation.
• Endovascualr treatment had been performed before stroke progression (thrombectomy, stent placement, balloon dilatation) or if surgery or interventional treatment had been scheduled;
• Current treatment with heparin therapy or oral anticoagulation (presumed cardiac source of embolus, such as atrial fibrillation, prosthetic cardiac valve, and known or suspected endocarditis);
• Previous diseases of the brain that include intracranial hemorrhage or amyloid angiopathy; brain surgery or hemorrhagic stroke; stroke within the last three months;
• Preexisting serious diseases: Cancer, AIDS, serious heart disease, dementia, liver diseases such as liver failure, cirrhosis, portal hypertension and active hepatitis, acute or chronic severe renal impairment (glomerular filtration rate \< 30 ml/min/1·73 m2 );
• Contraindication to aspirin or clopidogrel;
• Pregnant and lactating women.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin North Hospital of Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 201800, China

Location

Related Publications (3)

• Helleberg BH, Ellekjaer H, Indredavik B. Outcomes after Early Neurological Deterioration and Transitory Deterioration in Acute Ischemic Stroke Patients. Cerebrovasc Dis. 2016;42(5-6):378-386. doi: 10.1159/000447130. Epub 2016 Jun 29.

  PMID: 27351585 BACKGROUND

• Jorgensen HS, Nakayama H, Raaschou HO, Olsen TS. Effect of blood pressure and diabetes on stroke in progression. Lancet. 1994 Jul 16;344(8916):156-9. doi: 10.1016/s0140-6736(94)92757-x.

  PMID: 7912765 BACKGROUND

• Yang P, Song L, Zhang Y, Zhang X, Chen X, Li Y, Sun L, Wan Y, Billot L, Li Q, Ren X, Shen H, Zhang L, Li Z, Xing P, Zhang Y, Zhang P, Hua W, Shen F, Zhou Y, Tian B, Chen W, Han H, Zhang L, Xu C, Li T, Peng Y, Yue X, Chen S, Wen C, Wan S, Yin C, Wei M, Shu H, Nan G, Liu S, Liu W, Cai Y, Sui Y, Chen M, Zhou Y, Zuo Q, Dai D, Zhao R, Li Q, Huang Q, Xu Y, Deng B, Wu T, Lu J, Wang X, Parsons MW, Butcher K, Campbell B, Robinson TG, Goyal M, Dippel D, Roos Y, Majoie C, Wang L, Wang Y, Liu J, Anderson CS; ENCHANTED2/MT Investigators. Intensive blood pressure control after endovascular thrombectomy for acute ischaemic stroke (ENCHANTED2/MT): a multicentre, open-label, blinded-endpoint, randomised controlled trial. Lancet. 2022 Nov 5;400(10363):1585-1596. doi: 10.1016/S0140-6736(22)01882-7. Epub 2022 Oct 28.

  PMID: 36341753 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 13, 2024
• Study Start: August 15, 2024
• Primary Completion: July 15, 2025
• Study Completion: July 31, 2025
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: the study has finished
• Access Criteria: contact to the primary investigator

Locations

CN (1)