A single-center blinded crossover study investigating the efficacy of apixaban in patients with painful venous malformations with localized intravascular coagulation

Conditions

Venous malformation

Brief summary

Difference between apixaban and placebo in change of self-reported pain intensity before and 8 weeks after starting treatment

Detailed description

Difference between apixaban and placebo in change in coagulation parameters before and 8 weeks after starting treatment (Part 1), Difference between apixaban and placebo in change of quality of life before and 8 weeks after starting treatment (Part 1), Difference between apixaban and placebo in change of amount of thrombi in venous malformation before and after 8 weeks of treatment (Part 1), Change in pain intensity and quality of life three months after reducing dose (Part 2), Registering number and severity of bleeding episodes under treatment with apixaban and placebo (Part 1 and 2), Change in pain intensity 3 months after continuing apixaban 5 mg twice daily (Part 2)

Related papers

No related papers found yet.

Interventions

DRUGTeva GmbH filmovertrukne tabletter 5 mg

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Difference between apixaban and placebo in change of self-reported pain intensity before and 8 weeks after starting treatment	—

Secondary

Measure	Time frame
Difference between apixaban and placebo in change in coagulation parameters before and 8 weeks after starting treatment (Part 1), Difference between apixaban and placebo in change of quality of life before and 8 weeks after starting treatment (Part 1), Difference between apixaban and placebo in change of amount of thrombi in venous malformation before and after 8 weeks of treatment (Part 1), Change in pain intensity and quality of life three months after reducing dose (Part 2), Registering number and severity of bleeding episodes under treatment with apixaban and placebo (Part 1 and 2), Change in pain intensity 3 months after continuing apixaban 5 mg twice daily (Part 2)	—

Measure

Time frame

Difference between apixaban and placebo in change in coagulation parameters before and 8 weeks after starting treatment (Part 1), Difference between apixaban and placebo in change of quality of life before and 8 weeks after starting treatment (Part 1), Difference between apixaban and placebo in change of amount of thrombi in venous malformation before and after 8 weeks of treatment (Part 1), Change in pain intensity and quality of life three months after reducing dose (Part 2), Registering number and severity of bleeding episodes under treatment with apixaban and placebo (Part 1 and 2), Change in pain intensity 3 months after continuing apixaban 5 mg twice daily (Part 2)

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Countries

Norway

Outcome results

None listed