Pulmonary Embolism Clinical Trial
Official title:
A Prospective Study of Dabigatran Etexilate as Primary Treatment of Malignancy Associated Venous Thromboembolism
This trial aims at determining if dabigatran is effective in the treatment of malignancy
associated VTE. Tolerance and safety of dabigatran will also be assessed.
This is a single armed trial of dabigatran in patients with malignancy associated VTE.
The target recruitment is 99 consecutive patients with active malignancy and newly diagnosed
VTE (deep vein thrombosis and/or pulmonary embolism) in Queen Mary Hospital.
Tinzaparin 175 iu/kg daily will be started after the diagnosis of VTE is confirmed (duplex
Doppler ultrasonography for deep vein thrombosis, and computed tomography for pulmonary
embolism), and a written consent is obtained. Patients will be switched to dabigatran 150mg
twice daily from day 6 onwards. The first dose of dabigatran will be given within 2 hours
before the time that the next dose of tinzaparin would have been due. Anticoagulation will be
continued as long as malignancy is active. If patients achieve a complete remission of their
underlying malignancies, dabigatran will be continued for 6 months further.
Patients with malignancies are at increased risks of venous thromboembolism (VTE). The annual
incidence of VTE in cancer patients is 0.5%, which is 5-fold more than the general population
. Low molecular weight heparin (LMWH) has been the standard treatment for
malignancy-associated VTE. This recommendation follows the results of the Randomized
Comparison of Low-Molecular-Weight Heparin versus Oral Anticoagulant Therapy for the
Prevention of Recurrent VenousThromboembolism in Patients with Cancer (CLOT) trial, which
showed superiority of Low molecular weight heparin (LMWH) over warfarin in cancer patients
with VTE .
Low molecular weight heparin (LMWH) has a number of inherent advantages over warfarin. It
does not interact with chemotherapeutic agents, and dose titration is not necessary.
Furthermore, the risks of both bleeding and breakthrough VTE are also lower with LMWH.
However, the requirement of daily subcutaneous injection makes LWMH inconvenient to use. Most
patients have difficulties continuing daily injection, partly owing to compliance issues, but
also because an emaciated state in some patients makes subcutaneous injection painful. As the
life expectancy of solid cancer patients is improved with novel treatment options, the choice
of anticoagulation has become a major issue in the management of VTE in this patient
population.
The main reason underlying the inferior performance of warfarin in oncology patients is
difficult dose titration. Drug interaction and hepatic dysfunction are common in patients on
chemotherapy. Frequent interruptions of warfarin for invasive procedures and
chemotherapy-induced-thrombocytopenia also lead to fluctuations in anticoagulation level. As
a result, highs risk of recurrence of VTE and bleeding were observed in cancer patients
taking warfarin. Direct-acting oral anticoagulants (DOACs), on the other hand, may be an
attractive alternative treatment to LMWH. They are administered at a fixed dose with
predictable pharmacokinetics, so that therapeutic monitoring is not required. There is
minimal food and drug interaction. They have been shown to be effective in the treatment of
VTE in several pivotal randomized controlled trials in comparison with warfarin . However,
their role in malignancy associated VTE is yet to be determined, because cancer patients were
either excluded or very much underrepresented in these VTE treatment trials. Moreover, the
non-inferiority of DOACs in VTE treatment was only demonstrated against warfarin, which is
already shown to be suboptimal in oncology patients. A trial directly comparing DOACs with
LMWH in malignancy associated VTE is therefore needed.
Dabigatran etexilate is an oral thrombin inhibitor. It was shown in the RECOVER study to be
effective in treatment of VTE and it has a lower bleeding risk than warfarin. It is not
metabolized by cytochrome P450 system and therefore, in contrast to other DOACs, concomitant
administration of CYP3A4 inducers or inhibitors is not a concern.
We propose this prospective single armed trial to evaluate the efficacy and safety of
dabigatran in the treatment of malignancy associated VTE. We will compare the result with our
historical control who were treated with LMWH.
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