A Safety and Efficacy Trial Evaluating the Use of Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary Embolism.Estudio de seguridad y eficacia para evaluar el uso de apixaban en el tratamiento de la trombosis venosa profunda sintomática y el embolismo pulmonarRevised Protocol Number: 01, Incorporates amendment(s) 02+ Protocol Amendment 01 (version 1.0 dated 21-Apr-08) Site-specific - Molecular Profiling Supplement Samples For Pfizer’s Exploratory Research Biobank

Phase 1

• Conditions: Venous Thromboembolism (VTE)Tromboembolismo venoso (TEV); MedDRA version: 9.1Level: PTClassification code 10051055Term: Deep vein thrombosis; MedDRA version: 9.1Level: PTClassification code 10037377Term: Pulmonary embolism

• Registration Number: EUCTR2007-007867-25-ES
• Lead Sponsor: Bristol-Meyers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-07-14
• Study Completion: 2013-03-12
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 3625

Inclusion Criteria

a) Acute symptomatic proximal DVT with evidence of proximal thrombosis that involves at least the popliteal vein or a more proximal vein, demonstrated by imaging with:
- compression ultrasound (CUS), including grey-scale or color-coded Doppler,
or
- ascending contrast venography.
Or
b) Acute symptomatic PE with evidence of thrombosis demonstrated by imaging as follows:
- an intraluminal filling defect in segmental or more proximal branches on spiral CT scan; or
- an intraluminal filling defect or a sudden cutoff of vessels more than 2.5 mm in diameter on the pulmonary angiogram; or
- a perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scan (VPLS).
c) Men and women, ages 18 years or greater.
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Sex and Reproductive Status
a) WOCBP who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study.
b) Women who are pregnant or breastfeeding.
c) Women with a positive pregnancy test on enrollment or prior to investigational product administration.

2) Target Disease Exceptions
a) Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of VTE.
b) Active bleeding or high risk for bleeding contraindicating treatment with LMWH and a VKA.
c) Subjects with cancer who will be treated for 6-months or more with low molecular weight heparin therapy.
d) Subjects with contraindications according to the local prescribing information of enoxaparin or warfarin.

3) Medical History and Concurrent Diseases
a) Subjects with an indication, other than VTE, intended for long-term treatment with a VKA such as:
• Mechanical valve
• Atrial fibrillation or atrial flutter with moderate to high risk of systemic thromboembolism. Subjects with atrial fibrillation that appears to be associated with acute PE may participate.
b) Conditions for which serious bleeding may occur and the time of exclusion relative to the time of randomization: see chart list section 4.2.2.3
c) Active and clinically significant liver disease (eg, hepatorenal syndrome);
d) Life expectancy < 6 months;
e) Bacterial endocarditis;
f) Uncontrolled hypertension: systolic blood pressure > 180 mm Hg or diastolic blood pressure > 100 mm Hg; (subjects who have a transient, higher blood pressure elevation associated with acute PE [upper limit: systolic blood pressure 200 mm Hg or diastolic blood pressure 100 mm Hg] may enter the study;) elevated blood pressure that is persistent 1 - 2 days after the index DVT or PE should be treated according to local guidelines);

4) Physical and Laboratory Test Findings
a) Platelet count < 100,000/mm³ or hemoglobin < 9 g/dL
b) Serum creatinine > 2.5 mg/dL [221 umol/L] or a calculated creatinine clearance < 25 ml/min;
c) ALT or AST > 2 times upper limit of normal, or a total bilirubin > 1.5 times upper limit of normal (unless the latter has an alternative causative factor identified [eg, Gilbert’s syndrome]).

5) Allergies and Adverse Drug Reactions
a) Heparin induced thrombocytopenia;
b) Allergic reaction to unfractionated heparin, LMWH, fondaparinux or any VKA.

6) Prohibited Treatments and/or Therapies
a) DVT or PE treatment with more than two doses of fondaparinux or a LMWH that is labeled for once daily dosing, or more than three doses of a LMWH that is labeled for twice daily dosing, or continuous infusion of unfractionated heparin for more than 36 hours, before the first administration of study drug; and/or
b) DVT or PE treatment with more than two doses of oral VKA therapy before the first administration of study drug.
c) Treatment with apixaban in a previous clinical trial.
d) Subjects requiring ASA > 165 mg/day at randomization.
e) Subjects requiring dual anti-platelet therapy (ASA plus clopidogrel or ASA plus ticlopidine) at randomization. Subjects who transition from dual anti-platelet therapy to monotherapy prior to randomization will be eligible for the trial.

7) Other Exclusion Criteria
a) Prisoners or subjects who are involuntarily incarcerated
b) Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness;
c) Receiving concurrent investigational agents or has received an investigational

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified