Effectivity and Safety of PFO Closure Vs Medicine in Alleviating Migraine (SPRING)

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status and phase: Active, not recruiting; Phase 3

Conditions: PFO - Patent Foramen Ovale; Migraine

Treatments: Drug: Triptans; Device: PFO closure device; Drug: Aspirin and clopidogrel

Study type: Interventional

Funder types: Other

Identifiers

NCT04946734

SPRING2021

Details and patient eligibility

About

Effectivity and safety of PFO closure vs medicine in alleviating migraine （SPRING）: a multicenter, random, case control study

Enrollment: 440 estimated patients

Sex: All

Ages: 16 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Presence of PFO with right-to-left shunt, confirmed by Transthoracic.
2. Echocardiography (TTE) or transesophageal echocardiography (TEE) with a bubble study.
3. Bubble study positive confirmed by transcranial doppler.
4. Subject is diagnosed of migraine.
5. Subject signs an informed Consent Form and is willing to participate in follow-up visits

Exclusion criteria

1. Subject is diagnosed of headache with clear etiology.
2. Subject had cerebral hemorrhage, bleeding events in other organs within 3 months or was in high risk of bleeding.
3. Brain CT/MR showed ischemic lesions.
4. Subject is diagnosed of hepatic insufficiency: ALT or AST>3×ULN at the screening visit.
5. Subject is diagnosed of moderate to severe renal insufficiency: eGFR<30ml/min/1.73m2 at the screening visit.
6. Subject has uncontrolled arrhythmia with clinical significance within 90 days.
7. Subject is diagnosed of unstable angina, severe coronary atherosclerosis or myocardial infarction within 90 days.
8. Subject is diagnosed of pulmonary artery embolism, peripheral artery embolism or deep Vein Thrombosis.
9. Subject cannot follow the study procedure due to other acute or chronic diseases.
10. Subject is pregnant or lactating.
11. Subject is under other RCT.
12. Subject has a life expectancy <1 year.
13. Subject cannot follow the study procedure due to other reasons in the opinion of the investigators.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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440 participants in 2 patient groups

Test Arm

Experimental group

Description:

Device PFO closure

Treatment:

Drug: Aspirin and clopidogrel

Device: PFO closure device

Drug: Triptans

Control Arm

Other group

Description:

Drugs only

Treatment:

Drug: Aspirin and clopidogrel

Drug: Triptans