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Direct Oral Anticoagulant — Thrombin Inhibitor

Dabigatran (Stroke Prevention — AF)

Brand names: Pradaxa

This page covers dabigatran etexilate used for stroke and systemic embolism prevention in non-valvular atrial fibrillation, a direct oral anticoagulant.

Dosing — being independently re-sourced

ClinCalc Pro is rebuilding its dose data from primary open sources — the manufacturer SmPC (eMC), the WHO Model Formulary and other official references — under clinician review. This drug's structured dose is not yet published here. Confirm all doses against the product SmPC and your local formulary before prescribing.

Clinical monograph

How it works

Its active moiety is a reversible direct thrombin (factor IIa) inhibitor, preventing fibrin formation and thrombin-mediated platelet activation.

Prescribing in practice

  • It is substantially renally cleared and contraindicated in severe renal impairment, so renal function must be assessed before starting and the patient reassessed if function declines, given the bleeding risk of accumulation.
  • A specific reversal agent, idarucizumab, is available for emergency reversal in life-threatening bleeding or urgent surgery.
  • Capsules must not be removed from the blister or pill organiser until use and must be swallowed whole, as moisture exposure and opening the capsule markedly affect bioavailability.

Monitoring

Routine coagulation monitoring is not required, but check renal function at least annually and more often in renal impairment, the elderly or intercurrent illness.

Counselling the patient

  • Swallow capsules whole and keep them in the original packaging until taken.
  • Report bleeding, black stools, unusual bruising or significant falls.
  • Carry an anticoagulant alert card and inform clinicians before any procedure.

Evidence & guidelines

The RE-LY trial established dabigatran as effective for stroke prevention in atrial fibrillation compared with warfarin, supporting its NICE-recommended use.

Reference: RE-LY Trial (NEJM 2009); NICE NG196 (AF); MHRA DOAC Safety Update; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.