Trial Outcomes & Findings for Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus (NCT NCT02982590)

NCT ID: NCT02982590

Last Updated: 2021-07-08

Results Overview

Percentage of change in left ventricular thrombus (LVT) size after 12 weeks of Warfarin or Apixaban treatment

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 27 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2021-07-08

Participant Flow

Participant milestones

Measure	Warfarin Sodium warfarin daily, dosage according to INR monitor. Aim INR 2-3 Warfarin Sodium: as controlled arm since warfarin is the standard therapy for LV thrombus	Apixaban Apixaban 5 MG Oral Tablet \[ELIQUIS\] will be given for randomly selected patients for 3 months. Apixaban 5 MG Oral Tablet \[ELIQUIS\]: Apixaban is licensed for treatment of deep vein thrombosis and pulmonary embolism. Hence, a good study drug for left ventricular thrombosis for possibility of a new indication.
Overall Study STARTED	13	14
Overall Study COMPLETED	9	13
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Measure	Warfarin Sodium warfarin daily, dosage according to INR monitor. Aim INR 2-3 Warfarin Sodium: as controlled arm since warfarin is the standard therapy for LV thrombus	Apixaban Apixaban 5 MG Oral Tablet \[ELIQUIS\] will be given for randomly selected patients for 3 months. Apixaban 5 MG Oral Tablet \[ELIQUIS\]: Apixaban is licensed for treatment of deep vein thrombosis and pulmonary embolism. Hence, a good study drug for left ventricular thrombosis for possibility of a new indication.
Overall Study Lost to Follow-up	0	1
Overall Study Death	4	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Warfarin Sodium n=13 Participants warfarin daily, dosage according to INR monitor. Aim INR 2-3 Warfarin Sodium: as controlled arm since warfarin is the standard therapy for LV thrombus	Apixaban n=14 Participants Apixaban 5 MG Oral Tablet \[ELIQUIS\] will be given for randomly selected patients for 3 months. Apixaban 5 MG Oral Tablet \[ELIQUIS\]: Apixaban is licensed for treatment of deep vein thrombosis and pulmonary embolism. Hence, a good study drug for left ventricular thrombosis for possibility of a new indication.	Total n=27 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=13 Participants	0 Participants n=14 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=13 Participants	13 Participants n=14 Participants	24 Participants n=27 Participants
Age, Categorical >=65 years	2 Participants n=13 Participants	1 Participants n=14 Participants	3 Participants n=27 Participants
Age, Continuous	55.00 years STANDARD_DEVIATION 11.42 • n=13 Participants	55.36 years STANDARD_DEVIATION 11.04 • n=14 Participants	55.19 years STANDARD_DEVIATION 11.01 • n=27 Participants
Sex: Female, Male Female	1 Participants n=13 Participants	1 Participants n=14 Participants	2 Participants n=27 Participants
Sex: Female, Male Male	12 Participants n=13 Participants	13 Participants n=14 Participants	25 Participants n=27 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Comorbidities Diabetes mellitus	9 Participants n=13 Participants	7 Participants n=14 Participants	16 Participants n=27 Participants
Comorbidities Hypertension	9 Participants n=13 Participants	8 Participants n=14 Participants	17 Participants n=27 Participants
Comorbidities Ischemic heart disease	8 Participants n=13 Participants	9 Participants n=14 Participants	17 Participants n=27 Participants
Comorbidities Atrial fibrillation	0 Participants n=13 Participants	1 Participants n=14 Participants	1 Participants n=27 Participants
Comorbidities Chronic kidney disease	7 Participants n=13 Participants	5 Participants n=14 Participants	12 Participants n=27 Participants
Comorbidities Hyperlipidemia	9 Participants n=13 Participants	8 Participants n=14 Participants	17 Participants n=27 Participants
HAS-BLED score	1.46 total score STANDARD_DEVIATION 0.66 • n=13 Participants	1.0 total score STANDARD_DEVIATION 0.68 • n=14 Participants	1.22 total score STANDARD_DEVIATION 0.7 • n=27 Participants

PRIMARY outcome

Timeframe: 3 months

Percentage of change in left ventricular thrombus (LVT) size after 12 weeks of Warfarin or Apixaban treatment

Outcome measures

Measure	Warfarin Sodium n=13 Participants Warfarin daily, dosage according to INR monitor. Aim INR 2-3 Warfarin Sodium: as controlled arm since warfarin is the standard therapy for LV thrombus	Apixaban n=14 Participants Apixaban 5 MG Oral Tablet \[ELIQUIS\] will be given for randomly selected patients for 3 months. Apixaban 5 MG Oral Tablet \[ELIQUIS\]: Apixaban is licensed for treatment of deep vein thrombosis and pulmonary embolism. Hence, a good study drug for left ventricular thrombosis for possibility of a new indication.
Percent Change in Left Ventricular Thrombus (LVT) Size	-61.45 percentage of change Standard Deviation 43.95	-65.08 percentage of change Standard Deviation 31.34

SECONDARY outcome

Timeframe: 3 months

Percentage of participants who achieved left ventricular thrombus (LVT) reduction more than 50% in both Warfarin and Apixaban arms.

Outcome measures

Measure	Warfarin Sodium n=13 Participants Warfarin daily, dosage according to INR monitor. Aim INR 2-3 Warfarin Sodium: as controlled arm since warfarin is the standard therapy for LV thrombus	Apixaban n=14 Participants Apixaban 5 MG Oral Tablet \[ELIQUIS\] will be given for randomly selected patients for 3 months. Apixaban 5 MG Oral Tablet \[ELIQUIS\]: Apixaban is licensed for treatment of deep vein thrombosis and pulmonary embolism. Hence, a good study drug for left ventricular thrombosis for possibility of a new indication.
Change of Left Ventricular Thrombosis (LVT) by More Than 50%	77.7 percentage of participants	61.5 percentage of participants

SECONDARY outcome

Timeframe: 3 months

Number of participants who showed evidence of clinically definite cardiac embolic ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by CT scan

Outcome measures

Measure	Warfarin Sodium n=13 Participants Warfarin daily, dosage according to INR monitor. Aim INR 2-3 Warfarin Sodium: as controlled arm since warfarin is the standard therapy for LV thrombus	Apixaban n=14 Participants Apixaban 5 MG Oral Tablet \[ELIQUIS\] will be given for randomly selected patients for 3 months. Apixaban 5 MG Oral Tablet \[ELIQUIS\]: Apixaban is licensed for treatment of deep vein thrombosis and pulmonary embolism. Hence, a good study drug for left ventricular thrombosis for possibility of a new indication.
Clinically Definite Cardiac Embolic Ischemic Stroke	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 3 months

Number of participants who experienced life threatening bleeding attributed to the use of anti-coagulation.

Outcome measures

Measure	Warfarin Sodium n=13 Participants Warfarin daily, dosage according to INR monitor. Aim INR 2-3 Warfarin Sodium: as controlled arm since warfarin is the standard therapy for LV thrombus	Apixaban n=14 Participants Apixaban 5 MG Oral Tablet \[ELIQUIS\] will be given for randomly selected patients for 3 months. Apixaban 5 MG Oral Tablet \[ELIQUIS\]: Apixaban is licensed for treatment of deep vein thrombosis and pulmonary embolism. Hence, a good study drug for left ventricular thrombosis for possibility of a new indication.
Life Threatening Bleeding	1 Participants	0 Participants

Adverse Events

Warfarin Sodium

Serious events: 4 serious events

Other events: 1 other events

Deaths: 4 deaths

Apixaban

Serious events: 2 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Measure	Warfarin Sodium n=13 participants at risk Warfarin daily, dosage according to INR monitor. Aim INR 2-3 Warfarin Sodium: as controlled arm since warfarin is the standard therapy for LV thrombus	Apixaban n=14 participants at risk Apixaban 5 MG Oral Tablet \[ELIQUIS\] will be given for randomly selected patients for 3 months. Apixaban 5 MG Oral Tablet \[ELIQUIS\]: Apixaban is licensed for treatment of deep vein thrombosis and pulmonary embolism. Hence, a good study drug for left ventricular thrombosis for possibility of a new indication.
Cardiac disorders Death	15.4% 2/13 • Number of events 2 • 24 months	7.1% 1/14 • Number of events 1 • 24 months
Gastrointestinal disorders Gastrointestinal bleeding and Death	7.7% 1/13 • Number of events 1 • 24 months	0.00% 0/14 • 24 months
Cardiac disorders Sudden Death at home	7.7% 1/13 • Number of events 1 • 24 months	0.00% 0/14 • 24 months
Nervous system disorders Ischemic Stroke with hemorrhagic transformation and death	0.00% 0/13 • 24 months	7.1% 1/14 • Number of events 1 • 24 months

Other adverse events

Measure	Warfarin Sodium n=13 participants at risk Warfarin daily, dosage according to INR monitor. Aim INR 2-3 Warfarin Sodium: as controlled arm since warfarin is the standard therapy for LV thrombus	Apixaban n=14 participants at risk Apixaban 5 MG Oral Tablet \[ELIQUIS\] will be given for randomly selected patients for 3 months. Apixaban 5 MG Oral Tablet \[ELIQUIS\]: Apixaban is licensed for treatment of deep vein thrombosis and pulmonary embolism. Hence, a good study drug for left ventricular thrombosis for possibility of a new indication.
General disorders Epistaxis	7.7% 1/13 • Number of events 1 • 24 months	0.00% 0/14 • 24 months

Additional Information

DR W YUS HANIFF W ISA

HOSPITAL UNIVERSITI SAINS MALAYSIA

Phone: 09-767 3000

Email: wyhaniff@usm.my

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place