AMPLIFY (Apixaban for the Initial Management of Pulmonary Embolism and Deep-Vein Thrombosis as First-Line Therapy)
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Primary study

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Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism

Registry of Trials clinicaltrials.gov
Year 2008
Liens Registry of Trials

Cet article est inclus dans 1 Systematic review Systematic reviews (1 reference)

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The purpose of this study is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE)

Primary study

Unclassified

Efficacy and Safety Study of Apixaban for Extended Treatment of Deep Vein Thrombosis or Pulmonary Embolism

Registry of Trials clinicaltrials.gov
Year 2008
Liens Registry of Trials

Cet article est inclus dans 1 Systematic review Systematic reviews (1 reference)

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The purpose is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients who have completed their intended treatment for deep vein thrombosis (DVT) or pulmonary embolism (PE)

Primary study

Unclassified

Apixaban for the treatment of symptomatic deep-vein thrombosis and pulmonary embolism: a randomized, double-blind trial (AMPLIFY)

Journal JOURNAL OF THROMBOSIS AND HAEMOSTASIS
Year 2013

Cet article est inclus dans 2 Systematic reviews Systematic reviews (2 references)

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Primary study

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Oral apixaban for the treatment of acute venous thromboembolism.

Journal The New England journal of medicine
Year 2013
Liens Pubmed DOI Google Scholar

Cet article est inclus dans 39 Systematic reviews Systematic reviews (39 references) 1 Structured summary of primary studies Structured summaries of primary studies (1 reference) 2 Broad syntheses Broad syntheses (2 references)

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BACKGROUND: Apixaban, an oral factor Xa inhibitor administered in fixed doses, may simplify the treatment of venous thromboembolism. METHODS: In this randomized, double-blind study, we compared apixaban (at a dose of 10 mg twice daily for 7 days, followed by 5 mg twice daily for 6 months) with conventional therapy (subcutaneous enoxaparin, followed by warfarin) in 5395 patients with acute venous thromboembolism. The primary efficacy outcome was recurrent symptomatic venous thromboembolism or death related to venous thromboembolism. The principal safety outcomes were major bleeding alone and major bleeding plus clinically relevant nonmajor bleeding. RESULTS: The primary efficacy outcome occurred in 59 of 2609 patients (2.3%) in the apixaban group, as compared with 71 of 2635 (2.7%) in the conventional-therapy group (relative risk, 0.84; 95% confidence interval [CI], 0.60 to 1.18; difference in risk [apixaban minus conventional therapy], -0.4 percentage points; 95% CI, -1.3 to 0.4). Apixaban was noninferior to conventional therapy (P<0.001) for predefined upper limits of the 95% confidence intervals for both relative risk (<1.80) and difference in risk (<3.5 percentage points). Major bleeding occurred in 0.6% of patients who received apixaban and in 1.8% of those who received conventional therapy (relative risk, 0.31; 95% CI, 0.17 to 0.55; P<0.001 for superiority). The composite outcome of major bleeding and clinically relevant nonmajor bleeding occurred in 4.3% of the patients in the apixaban group, as compared with 9.7% of those in the conventional-therapy group (relative risk, 0.44; 95% CI, 0.36 to 0.55; P<0.001). Rates of other adverse events were similar in the two groups. CONCLUSIONS: A fixed-dose regimen of apixaban alone was noninferior to conventional therapy for the treatment of acute venous thromboembolism and was associated with significantly less bleeding (Funded by Pfizer and Bristol-Myers Squibb; ClinicalTrials.gov number, NCT00643201).

Primary study

Unclassified

Apixaban was noninferior to enoxaparin plus warfarin in patients with acute venous thromboembolism.

Auteurs Agnelli G.
Journal Annals of internal medicine
Year 2013

Cet article est inclus dans 1 Systematic review Systematic reviews (1 reference)

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Primary study

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Abstract PP5527: Apixaban for the treatment of venous thromboembolism in cancer patients: data from the AMPLIFY trial.

Journal European heart journal
Year 2014

Cet article est inclus dans 2 Systematic reviews Systematic reviews (2 references)

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Primary study

Unclassified

Apixaban for the treatment of venous thromboembolism in cancer patients

Journal Canadian Journal of Cardiology
Year 2014
Liens DOI Google Scholar

Cet article est inclus dans 1 Systematic review Systematic reviews (1 reference)

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BACKGROUND: Using data from AMPLIFY, a phase III trial comparing apixaban with conventional anticoagulant treatment in patients with venous thromboembolism (VTE), we performed subgroup analyses to compare the efficacy and safety of these regimens in patients with and without active cancer at baseline. Active cancer was defined as cancer that was diagnosed or treated within the past 6 months. METHODS: Patients with symptomatic VTE were randomized to a 6-month course of apixaban (10mg BID for 7 days followed by 5mg BID) or conventional treatment consisting of enoxaparin (1mg/kg BID for at least 5 days) followed by dose-adjusted warfarin (target INR, 2-3). Cancer patients for whom long-term low-molecular-weight heparin (LMWH) was planned were excluded. The primary efficacy outcome was symptomatic VTE or VTE-related death. The intent-to-treat efficacy analysis included all randomized subjects with a non-missing primary endpoint. The primary safety outcome was ISTH-defined major bleeding up to 2 days after stopping study drug in all randomized subjects who received at least one dose of study medication. All outcomes were adjudicated by an independent committee blinded to treatment assignment. RESULTS: Of 5395 patients randomized, 169 (3.1%) had active cancer. Baseline characteristics in these patients were similar between the two treatment groups. The median duration of treatment was 167 and 168 days in the apixaban and warfarin groups, respectively. In patients with active cancer at entry, recurrent VTE occurred in 3 of 81 (3.7%) patients in the apixaban group and in 5 of 78 (6.4%) in the warfarin group (relative risk [RR], 0.56; 95% CI, 0.13-2.37); major bleeding occurred in 2 of 87 (2.3%) and 4 of 80 (5.0%) patients, respectively (RR, 0.45; 95% CI, 0.08-2.46). In patients without cancer at entry, recurrent VTE occurred in 56 of 2528 (2.2%) and in 66 of 2557 (2.6%) patients in the apixaban and warfarin group, respectively (RR, 0.86; 95% CI, 0.60-1.22), whereas major bleeding occurred in 13 of 2589 (0.5%) and in 45 of 2609 (1.7%) patients in the apixaban and warfarin group, respectively (RR, 0.29; 95% CI, 0.16-0.54). CONCLUSION: Although the number of cancer patients was small, the results in this pre-specified subgroup are consistent with the overall findings and suggest that apixaban is as effective as conventional therapy in VTE patients with active cancer, and is associated with less bleeding. Additional studies are needed to compare the efficacy and safety of apixaban and LMWH for VTE treatment in cancer patients.

Primary study

Unclassified

Apixaban for the Treatment of Japanese Subjects With Acute Venous Thromboembolism (AMPLIFY-J Study).

Journal Circulation journal : official journal of the Japanese Circulation Society
Year 2015
Liens Pubmed DOI

Cet article est inclus dans 1 Systematic review Systematic reviews (1 reference)

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BACKGROUND: Anticoagulation is recommended as standard of care for venous thromboembolism (VTE) (pulmonary embolism [PE]/deep vein thrombosis [DVT]), for which unfractionated heparin (UFH) and warfarin are used in Japan. In the multi-regional AMPLIFY study, a fixed-dose regimen of apixaban alone was non-inferior to conventional therapy for treatment of PE/DVT and was associated with significantly fewer bleeding events. METHODS AND RESULTS: Japan phase 3 study (AMPLIFY-J), randomized, active-controlled, open-label study in Japanese subjects with acute PE/DVT, was designed based on AMPLIFY. Key objectives were to investigate safety and efficacy of apixaban in symptomatic PE/DVT subjects during 24-week treatment. UFH/warfarin was used as control treatment. Apixaban was initiated at 10 mg twice daily for 7 days, followed by 5 mg twice daily for 23 weeks. All endpoints and imaging for thrombotic burden were assessed by an event adjudication committee. Eighty subjects were randomized, 33 subjects (41.3%) were aged <65 years. Proportion of major/clinically relevant non-major bleeding was lower in apixaban (7.5%) compared with well-controlled UFH/warfarin (28.2%; median TTR, 70.4%). [corrected]. Recurrent VTE occurred in no subjects in apixaban and in 1 subject in UFH/warfarin. Thrombotic burden results were similar in both groups. Proportions of subjects with adverse events was generally similar in both groups. CONCLUSIONS: Apixaban was well-tolerated and had a favorable safety profile. No clinically important efficacy difference compared with UFH/warfarin was observed.

Primary study

Unclassified

Oral apixaban for the treatment of venous thromboembolism in cancer patients: results from the AMPLIFY trial.

Journal Journal of thrombosis and haemostasis : JTH
Year 2015
Liens Pubmed DOI

Cet article est inclus dans 3 Systematic reviews Systematic reviews (3 references)

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BACKGROUND: The AMPLIFY trial compared apixaban with enoxaparin followed by warfarin for the treatment of acute venous thromboembolism (VTE). OBJECTIVE: To perform a subgroup analysis to compare the efficacy and safety of apixaban and enoxaparin followed by warfarin for the treatment of VTE in patients with cancer enrolled in AMPLIFY. PATIENTS/METHODS: Patients with symptomatic VTE were randomized to a 6-month course of apixaban or enoxaparin followed by warfarin. The primary efficacy outcome and principal safety outcome were recurrent VTE or VTE-related death and major bleeding, respectively. RESULTS: Of the 5395 patients randomized, 169 (3.1%) had active cancer at baseline, and 365 (6.8%) had a history of cancer without active cancer at baseline. Among patients with active cancer, recurrent VTE occurred in 3.7% and 6.4% of evaluable patients in the apixaban and enoxaparin/warfarin groups, respectively (relative risk [RR] 0.56, 95% confidence interval [CI] 0.13-2.37); major bleeding occurred in 2.3% and 5.0% of evaluable patients, respectively (RR 0.45, 95% CI 0.08-2.46). Among patients with a history of cancer, recurrent VTE occurred in 1.1% and 6.3% of evaluable patients in the apixaban and enoxaparin/warfarin groups, respectively (RR 0.17, 95% CI 0.04-0.78); major bleeding occurred in 0.5% and 2.8% of treated patients, respectively (RR 0.20, 95% CI 0.02-1.65). CONCLUSIONS: The results of this subgroup analysis suggest that apixaban is a convenient option for cancer patients with VTE. However, additional studies are needed to confirm this concept and to compare apixaban with low molecular weight heparin in these patients.