Trial Outcomes & Findings for Colchicine to Prevent Post-Pericardiotomy Syndrome and Atrial Fibrillation (NCT NCT02177266)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

2 participants

Primary outcome timeframe

Baseline to 3 months

Results posted on

2017-06-21

Participant Flow

Subjects were enrolled at Mayo Clinic in Rochester, Minnesota.

Participant milestones

Participant milestones
Measure	Placebo A placebo pill (identical to the study drug Colchicine) will be given in a double-blinded fashion to study participants randomized to placebo.	Colchicine Colchicine 0.6mg bid will be given to study participants randomized to the study drug arm beginning at 48-72 hours prior to the planned cardiac surgery and then continued for a total of 30 days.
Overall Study STARTED	1	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo A placebo pill (identical to the study drug Colchicine) will be given in a double-blinded fashion to study participants randomized to placebo.	Colchicine Colchicine 0.6mg bid will be given to study participants randomized to the study drug arm beginning at 48-72 hours prior to the planned cardiac surgery and then continued for a total of 30 days.
Overall Study Adverse Event	0	1
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Colchicine to Prevent Post-Pericardiotomy Syndrome and Atrial Fibrillation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=1 Participants A placebo pill (identical to the study drug Colchicine) will be given in a double-blinded fashion to study participants randomized to placebo.	Colchicine n=1 Participants Colchicine 0.6mg bid will be given to study participants randomized to the study drug arm beginning at 48-72 hours prior to the planned cardiac surgery and then continued for a total of 30 days.	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 3 months

Population: The data were not analyzed because the 2 subjects enrolled withdrew before completing the study; the study was terminated early due to the difficulty in enrolling subjects.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 3 months

Population: The data were not analyzed because the 2 subjects enrolled withdrew before completing the study; the study was terminated early due to the difficulty in enrolling subjects.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline - 3 months

Population: The data were not analyzed because the 2 subjects enrolled withdrew before completing the study; the study was terminated early due to the difficulty in enrolling subjects.

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Colchicine

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=1 participants at risk A placebo pill (identical to the study drug Colchicine) will be given in a double-blinded fashion to study participants randomized to placebo.	Colchicine n=1 participants at risk Colchicine 0.6mg bid will be given to study participants randomized to the study drug arm beginning at 48-72 hours prior to the planned cardiac surgery and then continued for a total of 30 days.
Skin and subcutaneous tissue disorders Skin breakdown	0.00% 0/1 • 3 months	100.0% 1/1 • Number of events 1 • 3 months
Gastrointestinal disorders Nausea and dry heaves	0.00% 0/1 • 3 months	100.0% 1/1 • Number of events 1 • 3 months

Additional Information

Dr. Jae K. Oh

Mayo Clinic

Phone: 507-284-6055

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place