Pemafibrate for Symptomatic ICAS RCT

NCT07562178 | Not Yet Recruiting DMC

• 1 other identifier: JIHS-C-005243-00
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 19

Brief Summary

The goal of this clinical trial is to learn whether pemafibrate can help prevent worsening of intracranial arterial stenosis (ICAS) in patients who have symptomatic ICAS and high triglycerides (TG) levels after ischemic stroke or transient ischemic attack (TIA). The main questions this study aims to answer are:

• Be randomly assigned to a pemafibrate group or a non-pemafibrate group
• Take pemafibrate for 12 months if assigned to the pemafibrate group, with possible dose adjustment based on TG levels and kidney function
• Have blood tests and clinical assessments at baseline and during follow-up
• Undergo brain CTA at study entry and again at 12 months
• Undergo brain MRI/MRA and vascular tests such as ankle brachial index, cardio ankle vascular index, and pulse wave velocity according to the study schedule
• Be followed for vascular events, functional outcome, and adverse events for 1 year

Conditions

Hypertriglyceridaemia; Stroke (CVA) or TIA; Intracranial Atherosclerotic Disease (ICAD)

Outcome Measures

Primary Outcomes (1)

• Progression in intracranial arterial stenosis on CTA at 12 months from enrollment (progression vs. no progression [no change or improvement])

  Stenosis is assessed by the WASID method; progression is defined as an absolute increase of \>=10 percentage points in percent stenosis or the development of occlusion, stability as a change of \<10 percentage points in either direction, and improvement as an absolute decrease of \>=10 percentage points.

  Baseline and 12 months

Secondary Outcomes (16)

• Key secondary endpoint (supplementary analyses of the primary endpoint): Change in intracranial arterial stenosis on CTA at 12 months from enrollment (three categories: progression, no change, improvement)

  Baseline and 12 months

• Key secondary endpoint (supplementary analyses of the primary endpoint): Improvement in intracranial arterial stenosis on CTA at 12 months from enrollment (improvement vs. no improvement [progression or no change])

  Baseline and 12 months

• Change in percent stenosis by the WASID method

  Baseline and 12 months

• Proportion of intracranial arterial stenosis progression/improvement per the TOSS and TOSS-2 criteria

  Baseline and 12 months

• Proportion of intracranial arterial stenosis progression/improvement per the Wong KS criteria

  Baseline and 12 months

Study Arms (2)

Pemafibrate group

EXPERIMENTAL

Participants in this arm will receive pemafibrate in addition to standard medical therapy.

Drug: Pemafibrate

Non-pemafibrate group

NO INTERVENTION

Participants in this arm will receive standard medical therapy without pemafibrate.

Interventions

Pemafibrate DRUG

Participants in this arm will receive pemafibrate in addition to standard medical therapy.

Pemafibrate group

Eligibility Criteria

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

You may qualify if:

• Clinically stable ischemic stroke or high-risk TIA (ABCD2 score \>=4) between 24 hours and 3 years from onset at enrollment.
• Contrast-enhanced CT angiography (CTA) within 3 months prior to consent demonstrating 50-99% stenosis (WASID criteria) in a symptomatic intracranial artery: intracranial internal carotid artery, middle cerebral artery (M1/M2), anterior cerebral artery (A1), vertebral artery (V4), basilar artery, or posterior cerebral artery (P1).
• Fasting triglycerides (TG) 150-499 mg/dL, or non-fasting TG 175-499 mg/dL, measured within 4 weeks prior to consent.
• Men or women aged \>=18 years at the time of consent.
• Ability to obtain written informed consent from the patient or a legally authorized representative.

You may not qualify if:

• Patients with intracranial arterial stenosis due to non-atherosclerotic disorders (e.g., vasculitis, moyamoya disease, intracranial arterial dissection).
• Patients with \>=70% stenosis of the extracranial carotid artery (NASCET criteria).
• Patients with neurological deterioration within 24 hours prior to enrollment.
• Patients who received intravenous thrombolysis or mechanical thrombectomy within 24 hours prior to enrollment.
• Patients scheduled to undergo revascularization procedures (percutaneous transluminal angioplasty, stent placement, carotid endarterectomy, or cerebral bypass surgery).
• Patients who meet any contraindication to pemafibrate, including:
• (1) History of hypersensitivity to pemafibrate; (2) Severe hepatic impairment or liver cirrhosis classified as Child-Pugh B or C; (3) Cholelithiasis; (4) Pregnancy or suspected pregnancy; (5) Concomitant use of cyclosporine or rifampin. 7. Patients who have taken pemafibrate or any fibrate within 12 weeks prior to consent.
• \. Patients with contraindications to iodinated contrast media. 9. Patients on dialysis. 10. Patients with a history of pancreatitis attributable to hypertriglyceridemia.
• \. Patients with severe systemic comorbidities with an expected survival \<12 months.
• \. Patients who may be pregnant, are pregnant, or are breastfeeding. 13. Any other condition for which the principal or sub-investigator judges participation to be inappropriate.

Sponsors & Collaborators

• Tokyo Women's Medical University: lead
• Kowa Company, Ltd.: collaborator

Study Sites (19)

Iwate Medical University Hospital

Hizume, Iwate, 028-3695, Japan

Location

Kagoshima Medical Center

Kagoshima, Kagoshima-ken, 892-0853, Japan

Location

Kumamoto University Hospital

Kumamoto, Kumamoto, 860-8556, Japan

Location

Japanese Red Cross Kyoto Daini Hospital

Kyoto, Kyoto, 602-8026, Japan

Location

University Hospital Kyoto Prefectural University of Medicine

Kyoto, Kyoto, 602-8566, Japan

Location

Nagasaki University Hospital

Nagasaki, Nagasaki, 852-8501, Japan

Location

Kawasaki Medical School Hospital

Kurashiki, Okayama-ken, 701-0192, Japan

Location

Kansai Medical University Hospital

Hirakata, Osaka, 573-1191, Japan

Location

Osaka National Hospital

Osaka, Osaka, 540-0006, Japan

Location

Osaka General Medical Center

Osaka, Osaka, 558-8558, Japan

Location

Saitama Medical University International Medical Center

Hidaka, Saitama, 350-1298, Japan

Location

Japanese Red Cross Saitama Hospital

Saitama, Saitama, 330-8553, Japan

Location

Dokkyo Medical University Hospital

Mibu, Tochigi, 321-0293, Japan

Location

Jichi Medical University Hospital

Shimotsuke, Tochigi, 329-0498, Japan

Location

Showa General Hospital

Kodaira, Tokyo, 187-8510, Japan

Location

Kyorin University Hospital

Mitaka, Tokyo, 181-8611, Japan

Location

Tokyo Medical University Hospital

Shinjuku-Ku, Tokyo, 160-0023, Japan

Location

Tokyo Women's Medical University Hospital

Shinjuku-Ku, Tokyo, 162-8666, Japan

Location

University of Yamanashi Hospital

Chūō, Yamanashi, 409-3898, Japan

Location

Related Publications (4)

• Wong KS, Lam WW, Liang E, Huang YN, Chan YL, Kay R. Variability of magnetic resonance angiography and computed tomography angiography in grading middle cerebral artery stenosis. Stroke. 1996 Jun;27(6):1084-7. doi: 10.1161/01.str.27.6.1084.

  PMID: 8650718 BACKGROUND

• Kwon SU, Hong KS, Kang DW, Park JM, Lee JH, Cho YJ, Yu KH, Koo JS, Wong KS, Lee SH, Lee KB, Kim DE, Jeong SW, Bae HJ, Lee BC, Han MK, Rha JH, Kim HY, Mok VC, Lee YS, Kim GM, Suwanwela NC, Yun SC, Nah HW, Kim JS. Efficacy and safety of combination antiplatelet therapies in patients with symptomatic intracranial atherosclerotic stenosis. Stroke. 2011 Oct;42(10):2883-90. doi: 10.1161/STROKEAHA.110.609370. Epub 2011 Jul 28.

  PMID: 21799173 BACKGROUND

• Kwon SU, Cho YJ, Koo JS, Bae HJ, Lee YS, Hong KS, Lee JH, Kim JS. Cilostazol prevents the progression of the symptomatic intracranial arterial stenosis: the multicenter double-blind placebo-controlled trial of cilostazol in symptomatic intracranial arterial stenosis. Stroke. 2005 Apr;36(4):782-6. doi: 10.1161/01.STR.0000157667.06542.b7. Epub 2005 Mar 3.

  PMID: 15746463 BACKGROUND

• Chimowitz MI, Lynn MJ, Howlett-Smith H, Stern BJ, Hertzberg VS, Frankel MR, Levine SR, Chaturvedi S, Kasner SE, Benesch CG, Sila CA, Jovin TG, Romano JG; Warfarin-Aspirin Symptomatic Intracranial Disease Trial Investigators. Comparison of warfarin and aspirin for symptomatic intracranial arterial stenosis. N Engl J Med. 2005 Mar 31;352(13):1305-16. doi: 10.1056/NEJMoa043033.

  PMID: 15800226 BACKGROUND

MeSH Terms

Conditions

Hypertriglyceridemia; Stroke

Interventions

(R)-2-(3-((benzoxazol-2-yl-d4 (3-(4-methoxyphenoxy-d7)propyl)amino)methyl)phenoxy) butanoic acid

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Kenichi Todo, MD, PhD

CONTACT

+81-3-3353-8111; todo.kenichi@twmu.ac.jp

Takao Hoshino, MD, PhD

CONTACT

+81-3-3353-8111; hoshino.takao@twmu.ac.jp

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: April 20, 2026
• First Posted: May 1, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

JP (19)