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COMPLETED

NCT05546320

PHASE2

Comparison of the Effect of Medication Therapy in Alleviating Migraine With Patent Foramen Ovale

Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

View on ClinicalTrials.gov

Summary

Migraine attack is an episodic disorder that affects approximately 12% of the population. Previous studies have shown that 41-48% of migraineur have a combination of patent foramen ovale (PFO). Clinical observational studies have been linking medication therapies which include anticoagulation and anti-platelet therapy with the effectiveness in improving migraine symptoms and reducing the frequency of attacks in patients combined with a PFO. However, it has been unclear whether the effectiveness of anticoagulation or anti-platelet therapy outweigh the conventional migraine medication therapy, as a result, we designed a multi-center randomized clinical trial aiming to examine the effectiveness of anticoagulation versus anti-platelet versus migraine medication therapy in migraine patients with PFO and provide a clinical guidance for migraineur.

Official title: COMParison of the EffecT of mEdication Therapy: Anticoagulation Versus Anti-platelet Versus Migraine Therapy in Alleviating Migraine With Patent Foramen Ovale

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

1000

Start Date

2022-10-15

Completion Date

2025-03-26

Last Updated

2026-04-22

Healthy Volunteers

Conditions

Patent Foramen Ovale Migraine

Interventions

DRUG

Aspirin 300mg

Aspirin 300 mg was administered once daily for 12 weeks.

DRUG

Metoprolol 25mg

Metoprolol 25 mg was administered twice daily for 12 weeks.

DRUG

Clopidogrel 75mg

Clopidogrel 75 mg was administered once daily for 12 weeks.

DRUG

Rivaroxaban 20mg

Rivaroxaban 20 mg was administered once daily for 12 weeks.

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.

Locations (39)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

The First Affiliated Hospital of USTC

Hefei, Anhui, China

Suzhou Hospital of Anhui Medical University

Suzhou, Anhui, China

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

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

Beijing, Beijing Municipality, China

Gansu Provincial Hospital

Lanzhou, Gansu, China

The Second Affiliated Hospital of Lanzhou University

Lanzhou, Gansu, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Fuwai Hospital, Chinese Academy of Medical Sciences, Shenzhen Hospital

Shenzhen, Guangdong, China

The Seventh Affiliated Hospital of Sun Yat-sen University

Shenzhen, Guangdong, China

The First Affiliated Hospital, Guangxi Medical University

Nanning, Guangxi, China

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

Hebei General Hospital

Shijiazhuang, Hebei, China

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Xingtai People's Hospital

Xingtai, Hebei, China

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

Zunhua, Hebei, China

Daqing Longnan Hospital

Daqing, Heilongjiang, China

Nanyang Central Hospital

Nanyang, Henan, China

Shangqiu First People's Hospital

Shangqiu, Henan, China

Central China Fuwai Hospital of Zhengzhou University

Zhengzhou, Henan, China

Zhengzhou Central Hospital Affiliated to Zhengzhou University

Zhengzhou, Henan, China

Wuhan Asia Heart Hospital

Wuhan, Hubei, China

Xiangyang Central Hospital

Xiangyang, Hubei, China

Jiangxi Provincial People's Hospital Affiliated to Nanchang University

Nanchang, Jiangxi, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Dalian Municipal Central Hospital

Dalian, Liaoning, China

Dalian University Affiliated Zhongshan Hospital

Dalian, Liaoning, China

The Fourth People's Hospital of Shenyang

Shenyang, Liaoning, China

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

Yinchuan, Ningxia, China

The Second Hospital, Cheeloo College of Medicine, Shandong University

Jinan, Shandong, China

Qingdao Fuwai Cardiovascular Hospital

Qingdao, Shandong, China

Zibo Central Hospital Affiliated to Binzhou Medical College

Zibo, Shandong, China

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Clinical Medical College and Affiliated Hospital of Chengdu University

Chengdu, Sichuan, China

The First Affiliated Hospital of Chengdu Medical College

Chengdu, Sichuan, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

The Second Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Fuwai Cardiovascular Hospital of Yunnan Province

Kunming, Yunnan, China

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Clinical Research Directory

Comparison of the Effect of Medication Therapy in Alleviating Migraine With Patent Foramen Ovale

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (39)