Ticagrelor Therapy for RefrACTORy Migraine Study

Migraine Clinical Trial

— TRACTOR  

Official title:

Ticagrelor Therapy for RefrACTORy Migraine Study Pilot (TRACTOR)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02518464
• Other study ID #: AAAO4109
• Status: Completed
• Phase: Phase 4
• Start date: October 2015
• Est. completion date: October 2017

Study information

• Verified date: June 2019
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Migraine
• Migraine Disorders
• Migraine Headache

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Number of Responders	A participant will be considered to have achieved the primary efficacy endpoint (a "Responder") if she/he has >50% reduction in the number of monthly headache days during the month of therapy compared with participant's own baseline. If there is < 50% reduction in the number of migraine days, she/he will be considered a Non-Responder.	1 month from baseline