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Siste oppdatering 08 april 2016
L.NO.MKT.03.2016.1478

Secondary Prevention in Acute Coronary Syndrome: ATLAS

ATLAS is the abbreviation for Anti-Xa Therapy to Lower cardiovascular events in addition to Aspirin with/without thienopyridine therapy in Subjects with Acute Coronary Syndrome. It is an umbrella term for the clinical study programme of Xarelto® in the secondary prevention of Acute Coronary Syndrome. The ATLAS study programme is planned to enroll up to 19,500 patients.66

Objectives

There are 2 main objectives of ATLAS:
  • To evaluate the ability of Xarelto® to reduce the incidence of death, myocardial infarction (MI) or stroke in patients with recent ACS treated with Aspirin alone or Aspirin plus a thienopyridine
  • To evaluate the safety of Xarelto® in patients with recent ACS who are treated with Aspirin alone or Aspirin plus a thienopyridine
Xarelto® will be evaluated for safety and tolerability based on adverse events, clinical laboratory test, ECGs, vital signs measurements, and bleeding events.

ATLAS ACS TIMI 51: a phase lIl study to evaluate the efficacy and safety of Xarelto® in the secondary prevention of ACS

The ATLAS ACS TIMI 51 study is a global, phase III clinical study designed to evaluate the safety and efficacy of Xarelto® in addition to standard therapy.

Study design

The study is randomized, event-driven, placebo-controlled and double-blinded. It is planned to be initiated in late 2008 with a potential enrollment of up to 16,000 patients. All patients will receive standard antiplatelet therapy of low-dose aspirin with or without a thienopyridine, such as clopidogrel. Patients will then be randomized to additionally receive one of the following regimens for at least six month.
  • Xarelto® one 2.5 mg tablet, twice daily
  • Xarelto® one 5 mg tablet, twice daily
  • Placebo one tablet, twice daily
The primary efficacy endpoint of ATLAS ACS TIMI 51 is the composition of cardiovascular death, MI or stroke. The safety is assessed by the incidence of major bleeding events that are not associated with coronary artery bypass graft (CABG) surgery.66

ATLAS ACS TIMI 46: a phase ll dose-escalation study of Xarelto®

ATLAS ACS TIMI 46 is a phase II study of secondary prevention of acute coronary syndrome (ACS) to establish the safety and efficacy of Xarelto® in patients with recent ACS.20

Study design

ATLAS ACS TIMI 46 was a randomised, double-blind, placebo-controlled, multicentre, dose-escalation study conducted in about 3,500 post-ACS patients to evaluate Xarelto® in combination with Aspirin (stratum I) or Aspirin plus thienopyridine (stratum II) against antiplatelet therapy alone. Total daily doses of Xarelto® included 5, 10, 15, or 20 mg. The patients were assigned by the treating physician to the respective strata before they were randomly assigned to one of the following regimens:
  • Xarelto® one tablet once daily plus Aspirin alone or plus Aspirin and a thienopyridine
  • Xarelto® one tablet twice daily plus Aspirin alone or plus Aspirin and a thienopyridine
  • Placebo plus Aspirin alone or plus Aspirin and a thienopyridine
All groups received treatment for 6 months. The patients had a follow-up visit 1 month after the last study dose was given.20
The two doses selected for further evaluation in the pivotal Phase III programme – 2.5 mg and 5 mg dosed twice daily – showed the best balance between efficacy and safety.66



 

  • 66 - American Heart Association: Bayer’s Xarelto® Shows Encouraging results in Patients with Acute Coronary Syndrome [press release]. Leverkusen, Germany: Bayer HealthCare AG; November 10, 2008
  • 20 - A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Escalation and Dose-Confirmation Study to Evaluate the Safety and Efficacy of Rivaroxaban in Combination With Aspirin Alone or With Aspirin and a Thienopyridine in Subjects With Acute Coronary Syndromes. The ATLAS ACS TIMI 46 Trial (Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Aspirin With or Without Thienopyridine Therapy in Subjects With Acute Coronary Syndrome). Available at http://clinicaltrials.gov/ct2/show/NCT00402597. Accessed 13 August 2008.
Acute coronary syndrome
An umbrella term used to cover any group of clinical symptoms compatible with an acute heart attack. The subtypes of acute coronary syndrome include unstable angina (in which the heart muscle is not damaged), and two forms of heart attack in which the heart muscle is damaged. These latter types are named according to the appearance of the electrocardiogram as non-ST segment elevation myocardial infarction (NSTEMI) and ST segment elevation myocardial infarction (STEMI).
Efficacy
The ability of a drug to produce the desired effect.

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