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Direct Oral Thrombin Inhibitor — VTE / AF Stroke Prevention

Dabigatran

Brand names: Pradaxa

Dabigatran etexilate is an oral direct thrombin inhibitor used to prevent stroke in non-valvular atrial fibrillation and to treat and prevent venous thromboembolism.

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

It is a prodrug converted to dabigatran, which directly and reversibly inhibits free and clot-bound thrombin (factor IIa), preventing conversion of fibrinogen to fibrin.

Prescribing in practice

  • It is substantially renally cleared, so renal function must be assessed before and during treatment and the drug avoided or dose-adjusted in significant impairment to limit bleeding risk.
  • Absorption depends on P-glycoprotein, so interactions with verapamil, dronedarone and inducers such as rifampicin are relevant, and dyspepsia is a common adverse effect.
  • A specific reversal agent, idarucizumab, is available for life-threatening bleeding or emergency surgery.

Monitoring

Check renal function at baseline and at least annually, more often in the elderly or when function may decline, and review for signs of bleeding rather than routine coagulation testing.

Counselling the patient

  • Swallow capsules whole and keep them in the original blister or bottle to protect from moisture.
  • Report any unusual or prolonged bleeding.
  • Do not miss doses, and carry an anticoagulant alert card.

Evidence & guidelines

The RE-LY trial demonstrated dabigatran was at least as effective as warfarin for stroke prevention in atrial fibrillation, supporting its NICE-recommended use.

Reference: RE-LY Trial; RE-COVER Trial; NICE TA327 (Dabigatran for VTE); Idarucizumab REVERSE-AD Trial; 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.