Trial Outcomes & Findings for Anti-platelet Effects of Colchicine in Healthy Volunteers (NCT NCT02140372)

NCT ID: NCT02140372

Last Updated: 2016-02-23

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 10 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2016-02-23

Participant Flow

Participant milestones

Measure	Volunteer Group Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Anti-platelet Effects of Colchicine in Healthy Volunteers

Baseline characteristics by cohort

Measure	Volunteer Group n=10 Participants Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 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	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Measure	Volunteer Group n=10 Participants Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later
Monocyte Platelet Aggregate: Baseline	27.8 percentage of monocyte-platelet aggregat Interval 21.6 to 57.3

PRIMARY outcome

Timeframe: 2 Hours

Outcome measures

Measure	Volunteer Group n=10 Participants Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later
Monocyte Platelet Aggregate: 2 Hours	22 percentage of monocyte-platelet aggregat Interval 19.0 to 30.8

SECONDARY outcome

Timeframe: Baseline

In response to adenosine diphosphate

Outcome measures

Measure	Volunteer Group n=10 Participants Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later
Light Transmission Aggregometry: Baseline	48.7 percentage of max platelet aggregation Interval 33.5 to 85.3

SECONDARY outcome

Timeframe: 2 hours

In response to adenosine diphosphate

Outcome measures

Measure	Volunteer Group n=10 Participants Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later
Light Transmission Aggregometry: 2 Hours	66.6 percentage of max platelet aggregation Interval 23.6 to 87.3

SECONDARY outcome

Timeframe: baseline

In response to adenosine epinephrine

Outcome measures

Measure	Volunteer Group n=10 Participants Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later
Light Transmission Aggregometry: Baseline	84.9 percentage of max platelet aggregation Interval 61.8 to 90.2

SECONDARY outcome

Timeframe: 2 hours

In response to adenosine epinephrine

Outcome measures

Measure	Volunteer Group n=10 Participants Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later
Light Transmission Aggregometry: 2 Hours	84.6 percentage of max platelet aggregation Interval 48.6 to 87.7

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Measure	Volunteer Group n=10 Participants Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later
Platelet Adhesion: Baseline	10.2 percentage of adhered platelets Interval 2.5 to 32.6

SECONDARY outcome

Timeframe: 2 hours

Outcome measures

Measure	Volunteer Group n=10 Participants Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later
Platelet Adhesion: 2 Hours	2.0 percentage of adhered platelets Interval 0.2 to 9.5

Adverse Events

Volunteer Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Binita Shah

NYU School of Medicine

Phone: 212-263-4235

Email: binita.shah@nyumc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place