Clinical Guidance for Special Scenarios

The study medication should be temporarily discontinued in case of the following situations:

  1. an invasive procedure or surgical intervention that is associated with a standard or high risk of bleeding,
  2. requirement of any temporary or short-term anticoagulant therapy (including DVT prophylaxis),
  3. requirement of administration of a contraindicated medication, and
  4. a condition or illness where continuation of the study medication is not in the participant’s best interests.

Bridging heparin therapy is not required when the study medication is temporarily stopped for the intended indication of the TRACK trial.

Click on the appropriate box below to access specific guidance.