Early Identification of Warfarin Maintenance Dosage
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Purpose
Initiation of warfarin therapy is problematic. The investigators goal was to evaluate if a new demographic/pharmacogenetic algorithm is better than a usual algorithm based on INR value at day five after four days of 5 mg/day warfarin. To this end patients with atrial fibrillation starting warfarin are randomized in two arms.
| Condition | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation |
Genetic: Calculate warfarin dose using demographic/genetic algorithm |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Early Identification of Warfarin Maintenance Dose in Patients With Atrial Fibrillation: a Randomized Trial Evaluating a New Genotype-based Versus Usual Care Initiation of Treatment |
- International Normalized Ratio (INR) [ Time Frame: Day 0, 5, 7, 9, 12, 15, 19. ] [ Designated as safety issue: Yes ]Number of INR outside the therapeutic range (INR 2.0-3.0)
- Number of changes in warfarin dosage [ Time Frame: Day 0-19 ] [ Designated as safety issue: Yes ]
- Difference between predicted and actual warfarin maintenance dose [ Time Frame: Day 19 ] [ Designated as safety issue: Yes ]
- Thromboembolic and Bleeding complications [ Time Frame: Day 0-30 ] [ Designated as safety issue: Yes ]
| Enrollment: | 180 |
| Study Start Date: | October 2009 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: pharmacogenetic warfarin dose
Warfarin maintenance dose on the basis of demographic/pharmacogenetic data
|
Genetic: Calculate warfarin dose using demographic/genetic algorithm
Age, body weight and genetic to calculate warfarin dosage
|
Detailed Description:
The objective of this randomized study is to evaluate the accuracy of a new demographic/pharmacogenetic as compared to usual warfarin dosing algorithm in predicting warfarin maintenance dose. In patients with atrial fibrillation starting anticoagulation, the loading dose of warfarin in the tested group is calculated on the basis of VKORC1 genotype and patient's body weight.The second day warfarin maintenance dose is calculated on the basis of surface area and CYP2C9, CYP4F2 e VKORC1 genotype. In the usual care group the maintenance dose at day 5 is calculated on the basis of a published algorithm (Pengo V, Am J Cardiol 2001). INR is checked on day 0, 5, 7, 9, 12, 15 and 19. Primary end-point of the trial is the number of INR outside the therapeutic range of 2.0 to 3.0. Secondary end-points are the number of changes in dose prescription, the difference between predicted and actual warfarin maintenance dose and thrombotic and bleeding events.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age >18 years
- Indication to warfarin with INR between 2.0 and 3.0
Exclusion Criteria:
- Pregnancy
- Drug interactions
- Basal INR > 1.2
Contacts and Locations More Information
No publications provided
| Responsible Party: | Vittorio Pengo, Professor of Cardiology, University of Padova |
| ClinicalTrials.gov Identifier: | NCT01178034 History of Changes |
| Other Study ID Numbers: | 1643P |
| Study First Received: | August 6, 2010 |
| Last Updated: | October 21, 2012 |
| Health Authority: | Italy: The Italian Medicines Agency |
Keywords provided by University of Padova:
|
Warfarin Dose Pharmacogenetic INR |
Additional relevant MeSH terms:
|
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |
Warfarin Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013