Ticagrelor Therapy for RefrACTORy Migraine Study

NCT ID: NCT02518464

Last Updated: 2019-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-10-31

Brief Summary

This is a prospective, open-label, single-arm pilot study treating 40 subjects to assess the hypothesis that P2Y, G protein-coupled 12 (P2Y12) inhibition with Brilinta/ticagrelor (90 mg by mouth (PO) twice a day) reduces episodic and/or chronic migraine headache symptoms in patients with right to left shunt. Headache frequency while on Brilinta/ticagrelor will be compared with the documented baseline for each subject. If the Brilinta/ticagrelor therapy was effective (> 50% reduction in monthly headache days), the subject could elect to continue therapy for an additional two months (56 days), while continuing to complete daily headache logs.

Detailed Description

Migraine headaches are poorly understood, and can be severely debilitating. Many types of drugs have been tried in migraine sufferers including anti-depressants, anti-seizure medications, blood pressure medicines and others. The investigators have shown that in a small number of patients, a certain type of blood thinner (Clopidogrel) can reduce or eliminate migraine headaches in patients who also have a hole in the heart wall that allows flow from the right side of the heart to the left. Ticagrelor is a blood thinning drug which works in the same way as the clopidogrel, but is broken down by the body differently and thus allows everyone to use it. The investigators wish to test this medication to see if it works as well, or better than the clopidogrel.

Conditions

Migraine; Headache; Migraine Headache

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ticagrelor 90 mg twice per day

Interventions include the following: All participants will have a loading dose of Ticagrelor (Brilinta) 180 mg administered in the office at the time of enrollment. Thereafter, for 28 days, Ticagrelor 90 mg tablet will be taken once in the morning and once in the evening, as close to 12 hours apart as possible. Each day, the subject will receive a text message reminder to login to the website, to record her/his headache activity.

Group Type: EXPERIMENTAL

Ticagrelor 90 mg twice per day

Intervention Type: DRUG

Patients will be loaded with 180 mg of Ticagrelor during the enrollment office visit and provided with a 28 day supply of Ticagrelor, 90 mg twice per day. P2Y12 reactivity unit (PRU) testing will be conducted at 7-14 days. If the patient has a positive response, they will have the option of continued access of Ticagrelor 180 mg for another 2 months. Participants will be reminded via text message daily to complete a headache survey on line in order to track their headaches.

Interventions

Ticagrelor 90 mg twice per day

Patients will be loaded with 180 mg of Ticagrelor during the enrollment office visit and provided with a 28 day supply of Ticagrelor, 90 mg twice per day. P2Y12 reactivity unit (PRU) testing will be conducted at 7-14 days. If the patient has a positive response, they will have the option of continued access of Ticagrelor 180 mg for another 2 months. Participants will be reminded via text message daily to complete a headache survey on line in order to track their headaches.

Intervention Type: DRUG

Other Intervention Names

Brilinta

Eligibility Criteria

Inclusion Criteria

• At least one year history of Episodic or Chronic migraine headache symptoms
• At least 6 headache days per month
• Subject able to complete online daily headache log

Exclusion Criteria

• Inability to understand the study or history of non-compliance with medical advice
• Currently taking a P2Y12 inhibitor
• Known hypersensitivity to Brilinta/ticagrelor
• History of stroke/transient ischemic attack (TIA) in the previous 6 months
• Active bleeding from any site
• Active peptic ulcer disease or upper gastrointestinal (GI) bleeding within six (6) months
• Migraine onset after 50 years of age
• Renal impairment: Creatinine Clearance < 60 cc/min
• Severe hepatic impairment with total bilirubin > 3.0 mg/dL
• Thrombocytopenia with platelet count < 100,000 / ul
• History of intracranial hemorrhage
• Contraindications to blood thinner therapy or history of major bleeding episode while taking blood thinner therapy
• Need for chronic oral anti-coagulation therapy (i.e. Atrial Fibrillation)
• Need for chronic anti-platelet therapy (i.e. drug-eluting (DE) Stent), including daily aspirin use
• Need for daily nonsteroidal anti-inflammatory drug (NSAID) use
• Need for daily carbamazepine therapy or other strong CYP3A inhibitors or potent CYP3A inducers
• Need for simvastatin or lovastatin greater than 40 mg daily
• Symptomatic bradycardia or syncope
• Pregnancy or currently breast-feeding, or plan to become pregnant during the study period
• Planned surgery during the study time-frame
• Previously implanted patent foramen ovale (PFO), atrial septal defect (ASD), pacemaker, inferior vena cava filter, or left atrial appendage closure device

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Robert Sommer

Assistant Professor of Clinical Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert J Sommer, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Medical Center

New York, New York, United States

Countries

United States

References

Reisman AM, Robbins BT, Chou DE, Yugrakh MS, Gross GJ, Privitera L, Nazif T, Sommer RJ. Ticagrelor for Refractory Migraine/Patent Foramen Ovale (TRACTOR): An open-label pilot study. Neurology. 2018 Nov 27;91(22):1010-1017. doi: 10.1212/WNL.0000000000006573.

Reference Type: DERIVED

PMID: 30478067 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

AAAO4109

Identifier Type: -

Identifier Source: org_study_id