Close

move up move left move right move bottom

EINSTEIN Clinical Trial Program

The largest DVT and PE phase 3 clinical trial program ever conducted

The EINSTEIN clinical trial program consisted of three phase 3 clinical trials in more than 9400 patients:

A pooled analysis of the EINSTEIN–DVT and –PE trials was conducted, including key prespecified subgroups, such as fragile* patients, those with cancer, and those with previous VTE.1

EINSTEIN–DVT trial: Treating DVT

The EINSTEIN–DVT trial studied XARELTO® in patients with DVT and without PE The EINSTEIN–DVT trial studied XARELTO® in patients with DVT and without PE

The purpose of EINSTEIN–DVT was to compare the efficacy and safety of XARELTO® with standard therapy in 3449 patients with confirmed DVT (without symptomatic PE).2 XARELTO® was shown to be at least as effective as the standard of care (enoxaparin + warfarin). The safety data, pooled with the EINSTEIN–PE trial, showed comparable rates of the composite of major bleeding and clinically relevant nonmajor bleeding across treatment groups and lower rates of major bleeding for XARELTO®.1 View the study

  • Patients randomized to receive either XARELTO® or standard of care (enoxaparin + warfarin followed by warfarin) for 3, 6, or 12 months at physicians' discretion2

  • Primary efficacy outcome: symptomatic recurrent venous thromboembolism2

  • Principal safety outcome: composite of major bleeding and clinically relevant nonmajor bleeding2

EINSTEIN–PE trial: Treating PE

The EINSTEIN–PE trial studied XARELTO® in patients with PE and with or without DVT The EINSTEIN–PE trial studied XARELTO® in patients with PE and with or without DVT

The purpose of EINSTEIN–PE was to compare the efficacy and safety of XARELTO® with standard therapy in 4832 patients with confirmed PE (with or without symptomatic DVT).3 XARELTO® was proven at least as effective as the standard of care (enoxaparin + warfarin). The safety data, pooled with the EINSTEIN–DVT trial, showed comparable rates of the composite of major bleeding and clinically relevant nonmajor bleeding across treatment groups and lower rates of major bleeding for XARELTO®.1 View the study

  • Patients randomized to receive either XARELTO® or standard of care (enoxaparin + warfarin followed by warfarin) for 3, 6, or 12 months at physicians' discretion3

  • Primary efficacy outcome: symptomatic recurrent venous thromboembolism3

  • Principal safety outcome: composite of major bleeding and clinically relevant nonmajor bleeding3

Pooled subgroup analysis of the EINSTEIN–DVT and –PE trials

The purpose of the pooled analysis was to evaluate the combined efficacy and safety data of both trials. XARELTO® showed consistent outcomes versus standard of care (enoxaparin + warfarin) across prespecified subgroups.1 View the results

  • Both studies used identical designs, treatment regimens, outcome definitions, and adjudication processes to facilitate pooled analyses1

  • Key prespecified subgroups in the pooled analysis included fragile* patients, those with cancer, and those with previous VTE1

*Fragility was defined as one or more of these criteria: age >75 years, CrCl <50 mL/min, or body weight ≤50 kg.1

CrCl = creatinine clearance.

EINSTEIN–EXT trial: Extended risk reduction for DVT or PE

The EINSTEIN-EXT trial studied XARELTO® in patients with DVT or PE for extended treatment The EINSTEIN-EXT trial studied XARELTO® in patients with DVT or PE for extended treatment

The purpose of EINSTEIN–EXT was to establish the efficacy and safety profile of XARELTO® for longer-term treatment in 1196 patients with confirmed DVT or PE who had already completed their originally prescribed duration of anticoagulant therapy. In the study, continuing XARELTO® therapy was shown to provide extended risk reduction.2 View the study

  • All patients had already undergone 6 to 14 months of anticoagulation therapy and were at clinical equipoise with respect to the need for continued anticoagulation2

  • Patients randomized to receive either XARELTO® 20 mg once daily or placebo for an additional 6 or 12 months at physicians' discretion2

  • Primary efficacy outcome: symptomatic recurrent venous thromboembolism2

  • Principal safety outcome: major bleeding2

Longer than 6 months.

Although the EINSTEIN–EXT trial was designed to evaluate patients who had previously completed 6 to 12 months of treatment with either rivaroxaban or warfarin before trial enrollment, some of the patients could have received up to 14 months of anticoagulation treatment before enrollment.2

 

Indications

 

IMPORTANT SAFETY INFORMATION

 

Indication and Important saftey Information

 

  • Reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF). There are limited data on the relative effectiveness of XARELTO® (rivaroxaban) and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well controlled.
  • Treatment of deep vein thrombosis (DVT).
  • Treatment of pulmonary embolism (PE).
  • Reduction in the risk of recurrence of DVT and of PE following initial 6 months treatment for DVT and/or PE.
  • Prophylaxis of DVT, which may lead to PE in patients undergoing knee replacement surgery.
  • Prophylaxis of DVT, which may lead to PE in patients undergoing hip replacement surgery.

References:

  1. Prins MH, Lensing AWA, Bauersachs R, et al, on behalf of the EINSTEIN Investigators. Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies. Thromb J. 2013;11(1):21.
  2. The EINSTEIN Investigators. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010;363(26):2499-2510.
  3. The EINSTEIN–PE Investigators. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012;366(14):1287-1297.