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Intracranial Atherosclerotic Disease (ICAD)PPAR-ICASNCT07562178

Pemafibrate for Symptomatic ICAS RCT

A study testing Pemafibrate in people with Intracranial Atherosclerotic Disease (ICAD) and Hypertriglyceridaemia, run by Tokyo Women's Medical University at 37 sites in Japan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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: 1. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pemafibrate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
270 participants
Where
37 sitesJapan
Study dates
26 May 2026to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • 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.

Who cannot join

  • 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:
Show all 10Show fewer
  • 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.
  • 8. Patients with contraindications to iodinated contrast media. 9. Patients on dialysis. 10. Patients with a history of pancreatitis attributable to hypertriglyceridemia.
  • 11. Patients with severe systemic comorbidities with an expected survival <12 months.
  • 12. 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.

Trial locations and contacts

37 sites in 1 country. Contact the study team or a site near you to ask about taking part.

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

37 sites in 1 country

Japan37 sites, 37 recruiting

  • Tokyo Women's Medical University Adachi Medical Center

    Adachi-ku, Tokyo, 123-8558

    Sono Toi, +81-3-3857-0111, toi.sono@twmu.ac.jp

    Not yet recruiting

  • Institute of Science Tokyo Hospital

    Bunkyō-Ku, Tokyo, 113-8519

    Kazutaka Sumita, +81-3-3813-6111, sumita.nsrg@tmd.ac.jp

    Not yet recruiting

  • Nippon Medical School Hospital

    Bunkyō-Ku, Tokyo, 113-8603

    Satoshi Suda, suda-sa@nms.ac.jp

    Not yet recruiting

  • University of Yamanashi Hospital

    Chūō, Yamanashi, 409-3898

    Yuji Ueno, +81-55-273-1111, uenoy@yamanashi.ac.jp

    Recruiting

  • Brain Attack Center Ota Memorial Hospital

    Fukuyama, Hiroshima, 720-0825

    Yuka Terasawa, +81-84-931-8651, ykterasawa@shouwa.or.jp

    Not yet recruiting

  • Saitama Medical University International Medical Center

    Hidaka, Saitama, 350-1298

    Junya Aoki, +81-42-984-4111, aokijy@saitama-med.ac.jp

    Recruiting

  • Kansai Medical University Hospital

    Hirakata, Osaka, 573-1191

    Yusuke Yakushiji, +81-72-804-0101, yakushiji.yus@kmu.ac.jp

    Recruiting

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima, Hiroshima, 730-8518

    Tomoyuki Kono, +81-82-221-2291, t.kono1201@gmail.com

    Not yet recruiting

  • Iwate Medical University Hospital

    Hizume, Iwate, 028-3695

    Ryo Itabashi, +81-19-613-7111, ritabash@iwate-med.ac.jp

    Recruiting

  • Tokai University Hopital

    Isehara, Kanagawa, 259-1193

    Eiichiro Nagata, +81-463-93-1121, enagata@tokai.ac.jp

    Not yet recruiting

  • Kagoshima Medical Center

    Kagoshima, Kagoshima-ken, 892-0853

    Hideki Matsuoka, +81-99-223-1151, hmatsuok0124@yahoo.co.jp

    Recruiting

  • Nippon Medical School Musashikosugi Hospital

    Kawasaki, Kanagawa, 211-8533

    Kentaro Suzuki, +81-44-733-5181, kentarow@nms.ac.jp

    Not yet recruiting

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047

    Nobuyuki Ohara, +81-78-302-4321, nobuyukiohara@gmail.com

    Not yet recruiting

  • Showa General Hospital

    Kodaira, Tokyo, 187-8510

    Yutaka Honma, +81-42-461-0052, honma.yutaka@showa-hp.jp

    Recruiting

  • Kumamoto University Hospital

    Kumamoto, Kumamoto, 860-8556

    Makoto Nakajima, +81-96-344-2111, nakazima@kuh.kumamoto-u.ac.jp

    Recruiting

  • Kawasaki Medical School Hospital

    Kurashiki, Okayama-ken, 701-0192

    Yoshiki Yagita, +81-86-462-1111, yyagita@med.kawasaki-m.ac.jp

    Recruiting

  • Japanese Red Cross Kyoto Daini Hospital

    Kyoto, Kyoto, 602-8026

    Yoshinari Nagakane, +81-75-231-5171, ynagakane@gmail.com

    Recruiting

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, Kyoto, 602-8566

    Tomoyuki Ohara, +81-75-251-5111, ohatomo@koto.kpu-m.ac.jp

    Recruiting

  • Dokkyo Medical University Hospital

    Mibu, Tochigi, 321-0293

    Hidehiro Takegawa, +81-282-86-1111, take@dokkyomed.ac.jp

    Recruiting

  • The Jikei University Hspital

    Minato-Ku, Tokyo, 105-8471

    Kenichiro Sakai, +81-570-03-2222, k.sakai.0127@gmail.com

    Not yet recruiting

  • Tokyo Saiseikai Central Hospital

    Minato-Ku, Tokyo, 108-0073

    Koichi Oki, +81-3-3451-8211, koki.z8@keio.jp

    Not yet recruiting

  • Kyorin University Hospital

    Mitaka, Tokyo, 181-8611

    Teruyuki Hirano, +81-422-47-5511, terry@ks.kyorin-u.ac.jp

    Recruiting

  • Nagasaki University Hospital

    Nagasaki, Nagasaki, 852-8501

    Yohei Tateishi, +81-95-819-7200, ytate@nagasaki-u.ac.jp

    Recruiting

  • Osaka National Hospital

    Osaka, Osaka, 540-0006

    Shuhei Okazaki, +81-6-6942-1331, s-okazaki@osaka-njm.net

    Recruiting

  • Osaka Keisatsu Hospital

    Osaka, Osaka, 543-0042

    Yasutaka Murakami, +81-6-6771-6051, y.m.since20150916@gmail.com

    Recruiting

  • Osaka General Medical Center

    Osaka, Osaka, 558-8558

    Manabu Sakaguchi, +81-6-6692-1201, sakaguti@neurol.med.osaka-u.ac.jp

    Recruiting

  • Japanese Red Cross Saitama Hospital

    Saitama, Saitama, 330-8553

    Shuji Hino, +81-48-852-1111, shuji-hino@umin.org

    Recruiting

  • Kindai University Hopital

    Sakai, Osaka, 590-0197

    Kanta Tanaka, +81-72-288-7222, tanaka19830311kanta@gmail.com

    Not yet recruiting

  • Jichi Medical University Hospital

    Shimotsuke, Tochigi, 329-0498

    Shigeru Fujimoto, +81-285-44-2111, fujimotos1965@yahoo.co.jp

    Recruiting

  • Tokyo Medical University Hospital

    Shinjuku-Ku, Tokyo, 160-0023

    Hiroo Terashi, +81-3-3342-6111, terashi@tokyo-med.ac.jp

    Recruiting

  • Tokyo Women's Medical University Hospital

    Shinjuku-Ku, Tokyo, 162-8666

    Kenichi Todo, +81-3-3353-8111, todo.kenichi@twmu.ac.jp

    Recruiting

  • The University of Osaka Hospital

    Suita, Osaka, 565-0871

    Tsutomu Sakai, +81-6-6879-5111, sasaki@neurol.med.osaka-u.ac.jp

    Not yet recruiting

  • Nippon Medical School Tamanagayama Hospital

    Tama, Tokyo, 206-8512

    Tomonari Saito, +81-42-371-2111, s00-036@nms.ac.jp

    Not yet recruiting

  • Tokushima University Hospital

    Tokushima, Tokushima, 770-8503

    Yasushi Takagi, +81-88-631-3111, ytakagi@tokushima-u.ac.jp

    Not yet recruiting

  • Fujita Health University Hospital

    Toyoake, Aichi-ken, 470-1192

    Shoji Fujita, +81-562-93-2111, shoji.neuro@gmail.com

    Not yet recruiting

  • University of Tsukuba Hospital

    Tsukuba, Ibaraki, 305-8576

    Hiroshi Yamagami, +81-29-853-3900, yamagami.brain@outlook.com

    Not yet recruiting

  • Tokyo Women's Medical University Yachiyo Medical Center

    Yachiyo, Chiba, 276-8524

    Taichi Ishiguro, +81-47-450-6000, ishiguro.taichi@twmu.ac.jp

    Not yet recruiting

Other trials in Japan

About this study

Official title: Triglyceride-lowering Therapy With Pemafibrate for Prevention of Atherosclerotic Cardiovascular Disease in Patients With Symptomatic Intracranial Artery Stenosis: a Multi-center, Open-label, Randomized Controlled Trial (PPAR-ICAS)

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:

Read more
  1. Does pemafibrate lower the chance that ICAS gets worse over 12 months?
  2. Does pemafibrate improve TG levels and other vascular risk markers?
  3. What are the effects of pemafibrate on vascular events, functional outcomes, and safety over 12 months?

Researchers will compare a pemafibrate group with a non-pemafibrate group to see whether pemafibrate helps prevent progression of ICAS. This is an open-label, randomized, parallel-group trial. That means participants are assigned by chance to 1 of 2 groups, and both the researchers and participants know which group was assigned. Participants in both groups will continue to receive standard stroke care, including antithrombotic therapy and management of vascular risk factors such as blood pressure, low-density lipoprotein cholesterol, diabetes, and smoking.

Participants may be eligible if they are 18 years or older, have clinically stable ischemic stroke or TIA, have 50% to 99% stenosis in a symptomatic intracranial artery on contrast-enhanced CT angiography (CTA), and have elevated fasting (>=150 mg/dL) or non-fasting (>=175 mg/dL) TG levels. Some people will not be eligible, such as those with ICAS due to non-atherosclerotic arterial disease, severe extracranial carotid stenosis, recent intravenous thrombolysis or mechanical thrombectomy, planned revascularization, contraindications to pemafibrate or iodinated contrast media, dialysis, or pregnancy.

Participants will:

  • 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
Being tested
Pemafibrate
Medical subject headings
Hypertriglyceridemia, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PemafibrateDrug

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

Study groups in NCT07562178
Study groupRoleWhat they receive
Pemafibrate groupExperimentalParticipants in this arm will receive pemafibrate in addition to standard medical therapy.
Receives: Drug: Pemafibrate
Non-pemafibrate groupNo interventionParticipants in this arm will receive standard medical therapy without pemafibrate.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    If, during follow-up, emergency or unplanned revascularization (mechanical thrombectomy, percutaneous transluminal angioplasty, stent placement, or bypass surgery) is performed for the target culprit vessel lesion evaluated at registration in relation to progression or occlusion of that lesion, the case will be classified as "progression" regardless of the availability of CTA findings at 12 months.

    Measured: Baseline and 12 months

Secondary outcomes (16)

  1. 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)

    Measured: Baseline and 12 months

  2. 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])

    Measured: Baseline and 12 months

  3. Change in percent stenosis by the WASID method

    Measured: Baseline and 12 months

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

    Measured: Baseline and 12 months

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

    Measured: Baseline and 12 months

  6. Major cardiovascular events (MACE)

    The following individual events and their composite:

    Ischemic stroke (fatal, nonfatal), TIA, intracranial hemorrhage (fatal, nonfatal), any stroke (ischemic stroke, TIA, intracranial hemorrhage), emergency or unplanned revascularization procedures, including mechanical thrombectomy, percutaneous transluminal angioplasty, stent placement, or bypass surgery Myocardial infarction (fatal, nonfatal), any coronary artery disease event (myocardial infarction, or angina treated with PCI or CABG) Symptomatic peripheral artery disease (with intermittent claudication, ulceration, or gangrene; or requiring revascularization) Vascular death

    Measured: From enrollment to the end of treatment at 12 months

  7. All-cause mortality

    Measured: From enrollment to the end of treatment at 12 months

  8. Activities of daily living by mRS score (mRS 0-1, 0-2, and 0-3 proportions, and the overall mRS score distribution)

    The modified Rankin Scale (mRS) ranges from 0 to 6, with higher scores indicating greater disability or death; therefore, higher scores indicate a worse outcome.

    Measured: Baseline and 12 months

  9. Change in Fazekas scale on brain MRI

    Measured: Baseline and 12 months

  10. Change in number of cerebral microbleeds on brain MRI

    Measured: Baseline and 12 months

  11. Change in total cerebral small vessel disease score on brain MRI

    Measured: Baseline and 12 months

  12. Changes in ankle-brachial index (ABI)

    Measured: Baseline and 12 months

  13. Change in cardio-ankle vascular index (CAVI)

    Measured: Baseline and 12 months

  14. Change in pulse wave velocity (PWV)

    Measured: Baseline and 12 months

  15. Changes in blood biomarkers

    Complete blood count; fasting TG, HDL-C, LDL-C, RLP-C; apolipoprotein C-III; lipoprotein(a); fasting plasma glucose; HbA1c; AST, ALT, gamma-GTP; creatinine, eGFR; CK; CRP, high-sensitivity CRP; IL-6; total homocysteine; PT-INR; APTT; fibrinogen; D-dimer

    Measured: Baseline, 3 months, 6 months, and 12 months

  16. Safety: occurrence of adverse events and illnesses

    Measured: From enrollment to the end of treatment at 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2026
  2. Study start26 May 2026
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
270 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07562178
Sponsor's protocol ID
JIHS-C-005243-00
Acronym
PPAR-ICAS
Status last verified
Jul 2026
First submitted
20 Apr 2026
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 8650718

  • 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.

    PubMed 21799173

  • 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.

    PubMed 15746463

  • 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.

    PubMed 15800226

Questions about this trial

What is this clinical trial studying?

A study testing Pemafibrate in people with Intracranial Atherosclerotic Disease (ICAD) and Hypertriglyceridaemia, run by Tokyo Women's Medical University at 37 sites in Japan.

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 10 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: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in Japan. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kenichi Todo, MD, PhD (+81-3-3353-8111, todo.kenichi@twmu.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression in intracranial arterial stenosis on CTA at 12 months from enrollment (progression vs. no progression [no change or improvement]) (time frame: Baseline and 12 months). 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 NCT07562178, which also lists 4 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 3 Aug 2026.

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