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Trial record 91 of 590 for:    WARFARIN

Prothrombin Times Outside the Therapeutic Range in Otherwise Stable Patients (FORESPEAK-0)

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ClinicalTrials.gov Identifier: NCT00814177
Recruitment Status : Completed
First Posted : December 24, 2008
Results First Posted : November 25, 2009
Last Update Posted : August 1, 2012
Sponsor:
Information provided by (Responsible Party):
Sam Schulman, McMaster University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Atrial Fibrillation
Venous Thromboembolism
Ischemic Stroke
Myocardial Infarction
Intervention Drug: warfarin
Enrollment 160
Recruitment Details 160 patients were randomized at a single center during the period July 2006 – August 2008
Pre-assignment Details 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.
Arm/Group Title No Change Change
Hide Arm/Group Description Intervention Drug warfarin no change in the dose is performed Intervention Drug Warfarin One dose increased if subtherapeutic level; one dose deleted or reduced if supratherapeutic level
Period Title: Overall Study
Started 80 80
Completed 80 80
Not Completed 0 0
Arm/Group Title No Change Change Total
Hide Arm/Group Description Intervention Drug warfarin no change in the dose is performed Intervention Drug Warfarin One dose increased if subtherapeutic level; one dose deleted or reduced if supratherapeutic level Total of all reporting groups
Overall Number of Baseline Participants 80 80 160
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 80 participants 160 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
21
  26.3%
33
  41.3%
54
  33.8%
>=65 years
59
  73.8%
47
  58.8%
106
  66.3%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 80 participants 80 participants 160 participants
69.6  (11.4) 67.1  (13.8) 68.4  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 80 participants 160 participants
Female
31
  38.8%
34
  42.5%
65
  40.6%
Male
49
  61.3%
46
  57.5%
95
  59.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 80 participants 80 participants 160 participants
80 80 160
1.Primary Outcome
Title Number of Patients With Prothrombin Time Results Within the Therapeutic Range After 2 Weeks
Hide Description 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.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Change Change
Hide Arm/Group Description:
Intervention Drug warfarin no change in the dose is performed
Intervention Drug Warfarin One dose increased if subtherapeutic level; one dose deleted or reduced if supratherapeutic level
Overall Number of Participants Analyzed 80 80
Measure Type: Number
Unit of Measure: participants
48 45
Time Frame 2 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title No Change Change
Hide Arm/Group Description Intervention Drug warfarin no change in the dose is performed Intervention Drug Warfarin One dose increased if subtherapeutic level; one dose deleted or reduced if supratherapeutic level
All-Cause Mortality
No Change Change
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
No Change Change
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/80 (0.00%)      0/80 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
No Change Change
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/80 (2.50%)      1/80 (1.25%)    
Cardiac disorders     
ventricular tachycardia  [1]  1/80 (1.25%)  1 0/80 (0.00%)  0
Gastrointestinal disorders     
food poisoning   1/80 (1.25%)  1 0/80 (0.00%)  0
Reproductive system and breast disorders     
bleeding from penis   0/80 (0.00%)  0 1/80 (1.25%)  1
Indicates events were collected by systematic assessment
[1]
triggered by implanted defibrillator malfunction
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sam Schulman, MD
Organization: McMaster University
Phone: 1-905-5270271 ext 44479
EMail: schulms@mcmaster.ca
Layout table for additonal information
Responsible Party: Sam Schulman, McMaster University
ClinicalTrials.gov Identifier: NCT00814177     History of Changes
Other Study ID Numbers: HRC060425
First Submitted: December 23, 2008
First Posted: December 24, 2008
Results First Submitted: October 7, 2009
Results First Posted: November 25, 2009
Last Update Posted: August 1, 2012