Trial Outcomes & Findings for Prothrombin Times Outside the Therapeutic Range in Otherwise Stable Patients (NCT NCT00814177)

Last Updated: 2012-08-01

Results Overview

The number of patients with "follow-up INRs" within the therapeutic range was compared for patients with a single dose skipped/reduced/added versus patients with no change of dose.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

160 participants

Primary outcome timeframe

2 weeks

Results posted on

2012-08-01

Participant Flow

160 patients were randomized at a single center during the period July 2006 - August 2008

The study was planned for the sample size of 326 but due to competing studies, testing new dosing algorithms, the inclusion rate was much lower than expected.

Participant milestones

Participant milestones
Measure	No Change Intervention Drug warfarin no change in the dose is performed	Change Intervention Drug Warfarin One dose increased if subtherapeutic level; one dose deleted or reduced if supratherapeutic level
Overall Study STARTED	80	80
Overall Study COMPLETED	80	80
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prothrombin Times Outside the Therapeutic Range in Otherwise Stable Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	No Change n=80 Participants Intervention Drug warfarin no change in the dose is performed	Change n=80 Participants Intervention Drug Warfarin One dose increased if subtherapeutic level; one dose deleted or reduced if supratherapeutic level	Total n=160 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	21 Participants n=5 Participants	33 Participants n=7 Participants	54 Participants n=5 Participants
Age, Categorical >=65 years	59 Participants n=5 Participants	47 Participants n=7 Participants	106 Participants n=5 Participants
Age Continuous	69.6 years STANDARD_DEVIATION 11.4 • n=5 Participants	67.1 years STANDARD_DEVIATION 13.8 • n=7 Participants	68.4 years STANDARD_DEVIATION 12.7 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	34 Participants n=7 Participants	65 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants	46 Participants n=7 Participants	95 Participants n=5 Participants
Region of Enrollment Canada	80 participants n=5 Participants	80 participants n=7 Participants	160 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

The number of patients with "follow-up INRs" within the therapeutic range was compared for patients with a single dose skipped/reduced/added versus patients with no change of dose.

Outcome measures

Outcome measures
Measure	No Change n=80 Participants Intervention Drug warfarin no change in the dose is performed	Change n=80 Participants Intervention Drug Warfarin One dose increased if subtherapeutic level; one dose deleted or reduced if supratherapeutic level
Number of Patients With Prothrombin Time Results Within the Therapeutic Range After 2 Weeks	48 participants	45 participants

Adverse Events

No Change

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Change

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	No Change n=80 participants at risk Intervention Drug warfarin no change in the dose is performed	Change n=80 participants at risk Intervention Drug Warfarin One dose increased if subtherapeutic level; one dose deleted or reduced if supratherapeutic level
Cardiac disorders ventricular tachycardia	1.2% 1/80 • Number of events 1 • 2 weeks	0.00% 0/80 • 2 weeks
Gastrointestinal disorders food poisoning	1.2% 1/80 • Number of events 1 • 2 weeks	0.00% 0/80 • 2 weeks
Reproductive system and breast disorders bleeding from penis	0.00% 0/80 • 2 weeks	1.2% 1/80 • Number of events 1 • 2 weeks

Additional Information

Sam Schulman, MD

McMaster University

Phone: 1-905-5270271

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place