Trial Outcomes & Findings for Efficacy of RIvaroxaban for Prevention of Venous Thromboembolism After Knee Arthroscopy (NCT NCT01629381)

Results Overview

During the scheduled visit in case of suspected DVT a bilateral whole-leg colour-coded Doppler ultrasonography (CCDU) is scheduled for all patients at 7 (+1) days of follow-up; additionally, CCDU will be performed if the patients develop symptoms or signs suggestive of venous thromboembolism earlier; in case of suspected PE a multi-slice chest TC-angio is arranged; in case of death for all cause autoptic findings are requested or, if necessary, clinical ground is considered. A follow-up visit is planned 3-month period after the randomization.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

500 participants

Primary outcome timeframe

3-month period

Results posted on

2021-05-21

Participant Flow

Between apr2012 and Mar2014, 1278 subjects were evaluated for inclusion. Of them, 241 (19%) subjects accepted to participate. Due to the unexpectedly low recruitment rate, being a spontaneous study, we were forced to stop the trial before reaching the planned sample size because we were not able to afford insurance costs anymore.

Participant milestones

Participant milestones
Measure	Rivaroxaban Oral Rivaroxaban 10 mg od for 7 days Rivaroxaban: 10 mg os once daily for 1 week	Placebo oral placebo od for 7 days placebo: 10 mg os once daily for 1 week
Overall Study STARTED	122	119
Overall Study COMPLETED	120	114
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Rivaroxaban Oral Rivaroxaban 10 mg od for 7 days Rivaroxaban: 10 mg os once daily for 1 week	Placebo oral placebo od for 7 days placebo: 10 mg os once daily for 1 week
Overall Study Withdrawal by Subject	2	5

Baseline Characteristics

Efficacy of RIvaroxaban for Prevention of Venous Thromboembolism After Knee Arthroscopy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rivaroxaban n=122 Participants Oral Rivaroxaban 10 mg od for 7 days Rivaroxaban: 10 mg os once daily for 1 week	Placebo n=119 Participants oral placebo od for 7 days placebo: 10 mg os once daily for 1 week	Total n=241 Participants Total of all reporting groups
Age, Continuous	44.9 years STANDARD_DEVIATION 12.8 • n=99 Participants	45.9 years STANDARD_DEVIATION 13.9 • n=107 Participants	45.4 years STANDARD_DEVIATION 13.3 • n=206 Participants
Sex: Female, Male Female	44 Participants n=99 Participants	35 Participants n=107 Participants	79 Participants n=206 Participants
Sex: Female, Male Male	78 Participants n=99 Participants	84 Participants n=107 Participants	162 Participants n=206 Participants
Region of Enrollment Italy	122 participants n=99 Participants	119 participants n=107 Participants	241 participants n=206 Participants

PRIMARY outcome

Timeframe: 3-month period

Population: Drop-out: seven randomized patients withdrew consent on the day of surgery, without taking the study drug.

During the scheduled visit in case of suspected DVT a bilateral whole-leg colour-coded Doppler ultrasonography (CCDU) is scheduled for all patients at 7 (+1) days of follow-up; additionally, CCDU will be performed if the patients develop symptoms or signs suggestive of venous thromboembolism earlier; in case of suspected PE a multi-slice chest TC-angio is arranged; in case of death for all cause autoptic findings are requested or, if necessary, clinical ground is considered. A follow-up visit is planned 3-month period after the randomization.

Outcome measures

Outcome measures
Measure	Rivaroxaban n=120 Participants Oral Rivaroxaban 10 mg od for 7 days Rivaroxaban: 10 mg os once daily for 1 week	Placebo n=114 Participants oral placebo od for 7 days placebo: 10 mg os once daily for 1 week
Incidence of Symptomatic Venous Thromboembolism Plus Asymptomatic Proximal Vein Thrombosis and All-cause Mortality	1 participants	7 participants

PRIMARY outcome

Timeframe: 3 months

Population: No major bleeding events were observed during the study period.

Major bleeding include: clinically overt haemorrhage associated with haemoglobin drop of at least 2 g/L or requiring the transfusion of two or more units of packed red-blood cells; retroperitoneal or intracranial events; bleeding requiring re-intervention; and hemarthrosis with a joint drainage of more than 450 millilitres of blood.

Outcome measures

Outcome measures
Measure	Rivaroxaban n=114 Participants Oral Rivaroxaban 10 mg od for 7 days Rivaroxaban: 10 mg os once daily for 1 week	Placebo n=120 Participants oral placebo od for 7 days placebo: 10 mg os once daily for 1 week
Major Bleedings	0 participants	0 participants

SECONDARY outcome

Timeframe: 3 months

As described for the assessment of the primary efficacy outcomes

Outcome measures

Outcome measures
Measure	Rivaroxaban n=114 Participants Oral Rivaroxaban 10 mg od for 7 days Rivaroxaban: 10 mg os once daily for 1 week	Placebo n=120 Participants oral placebo od for 7 days placebo: 10 mg os once daily for 1 week
Combined Incidence of All DVT Plus Symptomatic PE	8 participants	2 participants

SECONDARY outcome

Timeframe: 3 months

As described for the primary safety outcome

Outcome measures

Outcome measures
Measure	Rivaroxaban n=114 Participants Oral Rivaroxaban 10 mg od for 7 days Rivaroxaban: 10 mg os once daily for 1 week	Placebo n=120 Participants oral placebo od for 7 days placebo: 10 mg os once daily for 1 week
Overall Incidence of Bleeding	6 participants	4 participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Rivaroxaban 10 mg for 7 Days

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=114 participants at risk oral placebo od for 7 days placebo: 10 mg os once daily for 1 week	Rivaroxaban 10 mg for 7 Days n=120 participants at risk Oral Rivaroxaban 10 mg od for 7 days Rivaroxaban: 10 mg os once daily for 1 week
General disorders skin reaction	0.00% 0/114 • 7 days on therapy and 90 days of follow-up	0.83% 1/120 • Number of events 1 • 7 days on therapy and 90 days of follow-up

Additional Information

Dr. Giuseppe Camporese

University of Padua

Phone: 049 8212882

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place