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Heart hole migraine sufferers: could blood thinners be the answer?

NCT ID NCT05546320

Symptom relief Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed Phase 2 trial tested whether blood thinners (rivaroxaban) or antiplatelet drugs (aspirin, clopidogrel) work better than standard migraine medication (metoprolol) for people with both migraine and a small heart hole called PFO. 1,000 participants took one of the four drugs daily for 12 weeks. The main goal was to see if the drugs cut migraine days or attacks by at least half.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Aspirin, metoprolol, clopidogrel, or rivaroxaban
What this could lead to
If it works, this could show that blood thinners or antiplatelet drugs are better than standard migraine meds for people with a PFO, offering a new treatment option.
What could go wrong
This is a completed Phase 2 trial, so results are still early. The drugs may not work better than existing migraine treatments, and blood thinners carry bleeding risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

1,000 people

The number who actually took part.

Started

Oct 2022

Finished

Mar 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 64 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria Participants must meet all of the following criteria: 1. Aged 18 to 64 years at Visit 1. 2. Diagnosis of migraine with or without aura confirmed by a neurologist, according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria. 3. History of migraine for more than 1 year, with an average of at least 4 migraine days per month during the 12-week screening period, as recorded in a headache diary and confirmed by the investigator at Visit 2. 4. Patent foramen ovale (PFO) diagnosed by transcranial Doppler (TCD), transthoracic echocardiography (TTE), or transesophageal echocardiography (TEE), with a right-to-left shunt at the atrial level. 5. Provision of written informed consent and willingness to comply with follow-up procedures. Exclusion Criteria Participants will be excluded if any of the following apply: 1. Secondary headache attributable to other causes. 2. History of transient ischemic attack, stroke, or intracranial hemorrhage. 3. History of pacemaker implantation, atrial septal defect closure, or left atrial appendage closure. 4. Right-to-left intracardiac shunt due to causes other than PFO. 5. Contraindications to antiplatelet or anticoagulant therapy, including thrombocytopenia, major trauma, active bleeding, decompensated cirrhosis, or drug allergy. 6. Contraindications to beta-blocker therapy, including hypotension, severe bradycardia, atrioventricular block, asthma, or drug allergy. 7. Poorly controlled atrial fibrillation at Visit 1. 8. Poorly controlled hypertension at Visit 1, defined as blood pressure \>160/90 mmHg despite regular medication. 9. Inability to maintain a headache diary or to reliably report headache symptoms. 10. Use of anticoagulants (e.g., warfarin, rivaroxaban) or antiplatelet agents (e.g., aspirin, clopidogrel, ticagrelor) within 12 weeks prior to Visit 2. 11. Use of metoprolol within 12 weeks prior to Visit 2. 12. Pregnancy, intention to become pregnant during the study period, or planned elective surgery during the study period. 13. Any condition that, in the investigator's opinion, may pose significant risk, confound study results, or interfere with participation. 14. Any other reasons (e.g., likely non-adherence, inability to attend follow-up visits, or planned relocation) that render the participant unsuitable for the study in the investigator's judgment.

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Conditions

The condition(s) this trial relates to.

migraine disorder patent foramen ovale

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Migraine Patent foramen ovale

Contacts and locations

Locations

  • Affiliated Zunhua People's Hospital of North China University of Science and Technology

    Zunhua, Hebei, China

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality, China

  • Central China Fuwai Hospital of Zhengzhou University

    Zhengzhou, Henan, China

  • Clinical Medical College and Affiliated Hospital of Chengdu University

    Chengdu, Sichuan, China

  • Dalian Municipal Central Hospital

    Dalian, Liaoning, China

  • Dalian University Affiliated Zhongshan Hospital

    Dalian, Liaoning, China

  • Daqing Longnan Hospital

    Daqing, Heilongjiang, China

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, China

  • Fuwai Cardiovascular Hospital of Yunnan Province

    Kunming, Yunnan, China

  • Fuwai Hospital, Chinese Academy of Medical Sciences, Shenzhen Hospital

    Shenzhen, Guangdong, China

  • Gansu Provincial Hospital

    Lanzhou, Gansu, China

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, China

  • Guizhou Provincial People's Hospital

    Guiyang, Guizhou, China

  • Hebei General Hospital

    Shijiazhuang, Hebei, China

  • Jiangxi Provincial People's Hospital Affiliated to Nanchang University

    Nanchang, Jiangxi, China

  • Nanyang Central Hospital

    Nanyang, Henan, China

  • National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, China

  • People's Hospital of Ningxia Hui Autonomous Region Affiliated to Ningxia Medical University

    Yinchuan, Ningxia, China

  • Qingdao Fuwai Cardiovascular Hospital

    Qingdao, Shandong, China

  • Shangqiu First People's Hospital

    Shangqiu, Henan, China

  • Suzhou Hospital of Anhui Medical University

    Suzhou, Anhui, China

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, China

  • The First Affiliated Hospital of Chengdu Medical College

    Chengdu, Sichuan, China

  • The First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, China

  • The First Affiliated Hospital of USTC

    Hefei, Anhui, China

  • The First Affiliated Hospital, Guangxi Medical University

    Nanning, Guangxi, China

  • The Fourth People's Hospital of Shenyang

    Shenyang, Liaoning, China

  • The Second Affiliated Hospital of Lanzhou University

    Lanzhou, Gansu, China

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, China

  • The Second Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, China

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, China

  • The Second Hospital, Cheeloo College of Medicine, Shandong University

    Jinan, Shandong, China

  • The Seventh Affiliated Hospital of Sun Yat-sen University

    Shenzhen, Guangdong, China

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, China

  • Wuhan Asia Heart Hospital

    Wuhan, Hubei, China

  • Xiangyang Central Hospital

    Xiangyang, Hubei, China

  • Xingtai People's Hospital

    Xingtai, Hebei, China

  • Zhengzhou Central Hospital Affiliated to Zhengzhou University

    Zhengzhou, Henan, China

  • Zibo Central Hospital Affiliated to Binzhou Medical College

    Zibo, Shandong, China

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