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RECORD Clinical Trial Program

Demonstrated efficacy and safety profile of DVT prophylaxis after knee or hip replacement surgery

The RECORD clinical trial program consisted of three rigorous, well-controlled, phase 3 clinical trials evaluating the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in more than 9000 patients undergoing knee or hip replacement surgery:

  • RECORD1, DVT prophylaxis after hip replacement surgery: XARELTO® versus enoxaparin

  • RECORD2, DVT prophylaxis after hip replacement surgery: extended-duration XARELTO® versus shorter-term enoxaparin

  • RECORD3, DVT prophylaxis after knee replacement surgery: XARELTO® versus enoxaparin

RECORD1 trial: DVT prophylaxis after hip replacement surgery

The RECORD1 trial studied XARELTO® for DVT prophylaxis after orthopedic surgery of the hip The RECORD1 trial studied XARELTO® for DVT prophylaxis after orthopedic surgery of the hip

The purpose of the RECORD1 trial was to compare the efficacy and safety of XARELTO® with enoxaparin for DVT prophylaxis in 4541 patients undergoing hip replacement surgery.1 XARELTO® delivered significant reductions in total VTE* and major VTE versus enoxaparin with comparable bleed rates.2 View the study

  • Patients were randomized to receive either1:

    • oral rivaroxaban 10 mg once daily for 31 to 39 days (with placebo injection), beginning 6 to 8 hours after wound closure, or

    • subcutaneous enoxaparin 40 mg once daily for 31 to 39 days (with placebo tablet), beginning 12 hours before surgery and resuming 6 to 8 hours after wound closure

  • Primary efficacy outcome: composite of any DVT, nonfatal PE, or death from any cause at 36 days (range, 30 to 42)1

  • Principal safety outcome: major bleeding, beginning after the first dose of study drug and for up to 2 days after the last dose1

RECORD2 trial: Extended DVT prophylaxis after hip replacement surgery

The RECORD2 trial studied XARELTO® for extended vs short-term DVT prophylaxis after orthopedic surgery of the hip The RECORD2 trial studied XARELTO® for extended vs short-term DVT prophylaxis after orthopedic surgery of the hip

The purpose of the RECORD2 trial was to compare the efficacy and safety of extended-duration XARELTO® with short-term enoxaparin for DVT prophylaxis in 2509 patients undergoing hip replacement surgery. Extended-duration XARELTO® was shown to provide significant reductions in total VTE* and major VTE with comparable major bleed rates versus short-term enoxaparin therapy.3 View the study

  • Patients were randomized to receive either3:

    • oral rivaroxaban 10 mg once daily for 31 to 39 days (with placebo injection for 10 to 14 days), beginning 6 to 8 hours after wound closure, or

    • subcutaneous enoxaparin 40 mg once daily for 10 to 14 days (with placebo tablet for 31 to 39 days), beginning 12 hours before surgery and resuming 6 to 8 hours after wound closure

  • Primary efficacy outcome: composite of DVT (symptomatic or asymptomatic detected by mandatory bilateral venography), nonfatal PE, and all-cause mortality up to day 30 to 42.3

  • Analyses were done in the modified intention-to-treat population, which consisted of all patients who had received at least one dose of study medication, had undergone planned surgery, and had adequate assessment of thromboembolism3

  • Principal safety outcome: major bleeding, beginning after the first dose of study drug and for up to 2 days after the last dose3

RECORD3 trial: DVT prophylaxis after knee replacement surgery

The RECORD3 trial studied XARELTO® for DVT prophylaxis after orthopedic surgery of the knee The RECORD3 trial studied XARELTO® for DVT prophylaxis after orthopedic surgery of the knee

The purpose of the RECORD3 trial was to compare the efficacy and safety of XARELTO® with enoxaparin for DVT prophylaxis in 2531 patients undergoing knee replacement surgery.4 XARELTO® delivered significant reductions in total VTE* and major VTE versus enoxaparin with comparable bleed rates. View the study

  • Patients were randomized to receive either4:

    • oral rivaroxaban 10 mg once daily for 10 to 14 days (with placebo injection), beginning 6 to 8 hours after wound closure, or

    • subcutaneous enoxaparin 40 mg once daily for 10 to 14 days (with placebo tablet), beginning 12 hours before surgery and resuming 6 to 8 hours after wound closure

  • Primary efficacy outcome: composite of any DVT, nonfatal PE, and all-cause mortality up to day 17 after surgery. Patients had mandatory bilateral venography between days 11 and 154

  • Principal safety outcome: major bleeding, beginning after the first dose of study drug and for up to 2 days after the last dose4

RECORD = REgulation of Coagulation in ORthopedic Surgery to Prevent Deep Venous Thrombosis and Pulmonary Embolism.

*Total VTE was a composite of proximal and/or distal DVT, nonfatal PE, and death from any cause.

Major VTE was a composite of proximal DVT, nonfatal PE, and VTE-related death.

Major bleeding was defined as bleeding that was fatal, bleeding into a critical organ (ie, retroperitoneal, intracranial, intraocular, or intraspinal), bleeding that required reoperation, or clinically overt extrasurgical site bleeding associated with a fall in hemoglobin ≥2 g/dL or requiring the transfusion of ≥2 units of blood or packed cells.

 

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. Eriksson BI, Borris LC, Friedman RJ, et al; for the RECORD1 Study Group. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med. 2008;358(26):2765-2775.
  2. Data on file. Janssen Pharmaceuticals, Inc.
  3. Kakkar AK, Brenner B, Dahl OE, et al; for the RECORD2 Investigators. Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial. Lancet. 2008;372(9632):31-39.
  4. Lassen MR, Ageno W, Borris LC, et al; for the RECORD3 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med. 2008;358(26):2776-2786.