Extended anticoagulation for thrombosis patients showing an activated coagulation system as detected by a simple blood test.

D-Dimer guided oral anticoagulation therapy for secondary prevention after venous thrombosis - D-Dimer guided OAT

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-006823-38-DE

Enrollment

300

Registered

2007-05-11

Start date

2007-08-14

Completion date

Unknown

Last updated

2022-01-17

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

Conditions

Female and male patients having suffered from venous thrombosis or pulmonary thromboembolism being treated with oral anticoagulant therapy (OAT)

Interventions

Trade Name: Falithrom Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Phenprocoumon CAS Number: 435-97-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: To be enrolled in this study, patients must •have an objectively confirmed first episode of unprovoced VTE or of VTE during a minor transient risk factor. Minor transient risk factors include - 6 weeks of estrogen therapy - prolonged air travel (i. e. > 6 hours) - pregnancy - less marked leg injuries or immobilization without injury or surgical intervention •be scheduled to receive oral anticoagulant treatment for at least 3 months •be willing to be randomized •be willing to participate for the full duration of the study Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120

Exclusion criteria

Exclusion criteria: Exclusion criteria include •pregnancy or breast feeding •contraindications against OAT (i. e. intracranial hemorrhage, subarachnoid hemorrhage, hemorrhagic stroke) •age < 18 years •presence of antiphospholipid antibodies or any other thrombophilic risk factor requiring long-term OAT (i. e. antithrombin deficiency, hereditary PC deficiency) •poor patient compliance

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of this study is to find out if a D-Dimer-guided algorithm for extension of oral anticoagulant treatment (OAT) will improve the quality of secondary prophylaxis after a first episode of venous thromboembolism (VTE). The primary hypothesis is to show superiority of extended OAT in patients showing persistently increased levels of D-Dimer after an initial episode of VTE as compared to no OAT in regard to the composite endpoint of recurrent DVT and major bleeding. ;Secondary Objective: The secondary hypothesis is to show that D-Dimer levels measured before stopping of OAT have the same predictive power to guide stopping or continuing anticoagulant treatment as D-Dimer levels measured 2 - 4 weeks after withdrawal of OAT.;Primary end point(s): The primary endpoint is recurrence of objectively documented VTE. The diagnosis of VTE will be performed to the AWMF guidelines.11 Patients with clinical symptoms of DVT during the observation period will be given a compression ultrasound examination or phlebography. Confirmation of PE is performed by spiral CT or MRI. Recurrent events will be classified as unprovoked or as secondary to known triggering factors. Patients will be instructed to report immediately to their treating center if they had symptoms of recurrent DVT and/or PE. The results of all diagnostic tests for DVT or pulmonary embolism performed during the study period will be independently reviewed by 2 experienced physicians who will not have knowledge of the patient´s initial D-Dimer result. For each patient who will die, the case will be independently reviewed by 2 reviewers not involved in the patient´s care. The cause of death will be determined without knowledge of the D-Dimer result at study entry. Disagreements between reviewers regarding the adjudication of VTE or the adjudicated cause of death will be resolved through independent adjudication by a third reviewer; the majority decision will be used as the outcome result. ;Timepoint	—

Measure

Time frame

Main Objective: The aim of this study is to find out if a D-Dimer-guided algorithm for extension of oral anticoagulant treatment (OAT) will improve the quality of secondary prophylaxis after a first episode of venous thromboembolism (VTE). The primary hypothesis is to show superiority of extended OAT in patients showing persistently increased levels of D-Dimer after an initial episode of VTE as compared to no OAT in regard to the composite endpoint of recurrent DVT and major bleeding. ;Secondary Objective: The secondary hypothesis is to show that D-Dimer levels measured before stopping of OAT have the same predictive power to guide stopping or continuing anticoagulant treatment as D-Dimer levels measured 2 - 4 weeks after withdrawal of OAT.;Primary end point(s): The primary endpoint is recurrence of objectively documented VTE. The diagnosis of VTE will be performed to the AWMF guidelines.11 Patients with clinical symptoms of DVT during the observation period will be given a compression ultrasound examination or phlebography. Confirmation of PE is performed by spiral CT or MRI. Recurrent events will be classified as unprovoked or as secondary to known triggering factors. Patients will be instructed to report immediately to their treating center if they had symptoms of recurrent DVT and/or PE. The results of all diagnostic tests for DVT or pulmonary embolism performed during the study period will be independently reviewed by 2 experienced physicians who will not have knowledge of the patient´s initial D-Dimer result. For each patient who will die, the case will be independently reviewed by 2 reviewers not involved in the patient´s care. The cause of death will be determined without knowledge of the D-Dimer result at study entry. Disagreements between reviewers regarding the adjudication of VTE or the adjudicated cause of death will be resolved through independent adjudication by a third reviewer; the majority decision will be used as the outcome result. ;Timepoint

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Secondary

Measure	Time frame
Secondary end point(s): Incidence and severity of signs and symptoms associated with oral anticoagulant treatment associated bleeding measured using the World Health Organization (WHO) bleeding scale.;Timepoint(s) of evaluation of this end point: The occurrence of major bleeding will be documented through the adverse event reporting system. The occurrence of minor bleeding events will be documented at each study visit.	—

Measure

Time frame

Secondary end point(s): Incidence and severity of signs and symptoms associated with oral anticoagulant treatment associated bleeding measured using the World Health Organization (WHO) bleeding scale.;Timepoint(s) of evaluation of this end point: The occurrence of major bleeding will be documented through the adverse event reporting system. The occurrence of minor bleeding events will be documented at each study visit.

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Countries

Germany

Contacts

Public ContactInstitut für Experimentelle Hämatol

Universitätsklinikum Bonn

bernd.poetzsch@ukb.uni-bonn.de+4922828716745

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026