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The efficacy of different warfarin starting doses (3 mg versus 5 mg) and the corresponding dosing schedule in patients diagnosed with deep vein thrombosis

The efficacy of different warfarin initiating doses (3 mg versus 5 mg) and the corresponding dosing schedule in patients diagnosed with venous thromboembolism

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20180328002
Enrollment
Unknown
Registered
2018-03-28
Start date
2009-08-01
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The efficacy of different warfarin initiating dose in patients diagnosed with venous thromboembolism warfarin&#44

Interventions

The eligible patients were randomized by blocked randomization to receive a warfarin initiating dose of 3 mg or 5 mg per day for the first 2 consecutive days (day 1 and day 2). The first day of warfar
and then heparin therapy was discontinued. The choice of heparin treatment was made according to the attending physician’s discretion. Blood samples were collected from venipuncture and were sent fo
INR&#44
aPTT&#44
complete blood count and a liver function test prior to the initiation of warfarin anticoagulant therapy. In addition&#44
blood for INR testing was collected on days 3&#44
5 and 8 of warfarin treatment. Furthermore&#44
blood samples were drawn and sent for evaluation of single nucleotide polymorphisms (SNPs) of the CYP2C9 and VKORC1 genes. The enrolled inpatients or outpatients were followed on days 3&#44
and 8 of warfarin treatment. ,The eligible patients were randomized by blocked randomization to receive a warfarin initiating dose of 3 mg or 5 mg per day for the first 2 consecutive days (day 1 and d
and then heparin therapy was discontinued. The choice of heparin treatment was made according to the attending physician’
Active Comparator Drug,Active Comparator Drug
Warfarin 3&#45
mg initiating dose and corresponding dosing schedule,Warfarin 5&#45
mg initiating dose and corresponding dosing schedule

Sponsors

Faculty of Medicine Siriraj Hospital, Mahidol University
Lead Sponsor
Thai Society of Hematology
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult patients aged 18 years or older who were diagnosed with symptomatic proximal deep vein thrombosis (DVT) of the extremity or DVT at other unusual sites (for example, cerebral venous sinus thrombosis, and/or pulmonary embolism (PE)) and planned to receive warfarin with a target INR of 2.0–3.0.

Exclusion criteria

Exclusion criteria: An absolute contraindication to anticoagulant therapy (e.g., active bleeding), high risk of bleeding (e.g., recent eye, brain or spinal cord surgery within 3 months), history of concurrent congestive heart failure, history of liver cirrhosis (Child Pugh class B or C), concomitant use of aspirin, prolonged baseline PT and/or activated partial thromboplastin time (aPTT) above the upper normal limits, platelet counts of less than 50×109/L, serum albumin less than 2.0 g/dL, pregnancy, and patients who were unable to perform oral feeding

Design outcomes

Primary

MeasureTime frame
Efficacy of warfarin initiating dose and the corresponding dosing schedule 8 days The number of patients who achieved the INR of 2.0–3.0 within 8 days after treatment

Secondary

MeasureTime frame
Bleeding complication 8 days The incidence of bleeding complications within 8 days or INR > 5.0 ,Characteristics of CYP2C9 and VKORC1 single nucleotide polymorphisms 8 days Genotyping of CYP2C9 and VKORC1

Countries

Thailand

Contacts

Public ContactBundarika Suwanawiboon

Faculty of Medicine Siriraj Hospital

bundarika@gmail.com024197000

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026