Trial Outcomes & Findings for Ticagrelor Therapy for RefrACTORy Migraine Study (NCT NCT02518464)
NCT ID: NCT02518464
Last Updated: 2019-06-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
1 month from baseline
Results posted on
2019-06-04
Participant Flow
Study subjects were recruited from the hospital-based cardiology and headache clinics at Columbia University Medical Center and through the private offices of the study physicians. All subjects were evaluated by a Neurologist and fulfilled MHA criteria of the International Classification of Headache Disorders (ICHD - 3 Beta).
Participant milestones
| Measure |
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.
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.
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
38
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
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.
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.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
Ticagrelor Therapy for RefrACTORy Migraine Study
Baseline characteristics by cohort
| Measure |
Ticagrelor 90 mg Twice Per Day
n=40 Participants
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.
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 month from baselineA 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.
Outcome measures
| Measure |
Ticagrelor 90 mg Twice Per Day
n=40 Participants
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.
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.
40 subjects were enrolled.
|
|---|---|
|
Total Number of Responders
|
17 Participants
|
Adverse Events
Ticagrelor 90 mg Twice Per Day
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ticagrelor 90 mg Twice Per Day
n=40 participants at risk
Two patients did not complete the TRACTOR Trial protocol due to adverse medication side effects, and five other patients had mild systemic symptoms which were potentially related to ticagrelor. Five additional patients reported unusual bruising while on ticagrelor but had no other clinical issues and completed the trial protocol. There were no significant bleeding issues in any patient treated with ticagrelor. All adverse medication effects were evaluated by the TRACTOR Trial DSMB. None were deemed to be a serious adverse event.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Bruising
|
12.5%
5/40 • Number of events 5 • 3 months
|
|
Gastrointestinal disorders
mild systemic symptoms
|
12.5%
5/40 • Number of events 5 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place