Trial Outcomes & Findings for Safety of Argatroban Infusion in Conduction Disturbances (NCT NCT05740371)
NCT ID: NCT05740371
Last Updated: 2025-12-30
Results Overview
It was investigated if a mean QTc prolongation of more than 10 ms occurred between ECG-2 and ECG-1
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
50 participants
Primary outcome timeframe
ECG-2 was recorded immediately after cardiac intervention when patient was fully anticoagulated with argatroban and ECG-1 was recorded at baseline prior to first bolus dose of argatroban (argatroban-free status).
Results posted on
2025-12-30
Participant Flow
Participant milestones
| Measure |
Argatroban Intravenous (i.v.) Bolus & i.v. Infusion
i.v. bolus of 300 μg/kg argatroban administered over a span of 3 to 5 minutes followed by the i.v. infusion of argatroban at 20 μg/kg/min until the end of the procedure.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
49
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Argatroban Intravenous (i.v.) Bolus & i.v. Infusion
i.v. bolus of 300 μg/kg argatroban administered over a span of 3 to 5 minutes followed by the i.v. infusion of argatroban at 20 μg/kg/min until the end of the procedure.
|
|---|---|
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Overall Study
Death
|
1
|
Baseline Characteristics
Safety of Argatroban Infusion in Conduction Disturbances
Baseline characteristics by cohort
| Measure |
Argatroban Intravenous (i.v.) Bolus & i.v. Infusion
n=50 Participants
i.v. bolus of 300 μg/kg argatroban administered over a span of 3 to 5 minutes followed by the i.v. infusion of argatroban at 20 μg/kg/min until the end of the procedure.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=174 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=174 Participants
|
|
Age, Categorical
>=65 years
|
26 Participants
n=174 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=174 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=174 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=174 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=174 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=174 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=174 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=174 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=174 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=174 Participants
|
PRIMARY outcome
Timeframe: ECG-2 was recorded immediately after cardiac intervention when patient was fully anticoagulated with argatroban and ECG-1 was recorded at baseline prior to first bolus dose of argatroban (argatroban-free status).It was investigated if a mean QTc prolongation of more than 10 ms occurred between ECG-2 and ECG-1
Outcome measures
| Measure |
Argatroban Intravenous (i.v.) Bolus & i.v. Infusion (ITT Population/Centre 01)
n=50 Participants
i.v. bolus of 300 μg/kg argatroban administered over a span of 3 to 5 minutes followed by the i.v. infusion of argatroban at 20 μg/kg/min until the end of the procedure in Centre 01.
|
Argatroban Intravenous (i.v.) Bolus & i.v. Infusion (ITT Population/Centre 02)
i.v. bolus of 300 μg/kg argatroban administered over a span of 3 to 5 minutes followed by the i.v. infusion of argatroban at 20 μg/kg/min until the end of the procedure in Centre 02.
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|---|---|---|
|
Mean Difference in QTc Interval Between ECG-2 and ECG-1 (ITT Population)
|
0.94 milliseconds
Standard Deviation 46.37
|
—
|
PRIMARY outcome
Timeframe: ECG-2 was recorded immediately after cardiac intervention when patient was fully anticoagulated with argatroban and ECG-1 was recorded at baseline prior to first bolus dose of argatroban (argatroban-free status).It was investigated if a mean QTc prolongation of more than 10 ms occurred between ECG-2 and ECG-1
Outcome measures
| Measure |
Argatroban Intravenous (i.v.) Bolus & i.v. Infusion (ITT Population/Centre 01)
n=39 Participants
i.v. bolus of 300 μg/kg argatroban administered over a span of 3 to 5 minutes followed by the i.v. infusion of argatroban at 20 μg/kg/min until the end of the procedure in Centre 01.
|
Argatroban Intravenous (i.v.) Bolus & i.v. Infusion (ITT Population/Centre 02)
n=11 Participants
i.v. bolus of 300 μg/kg argatroban administered over a span of 3 to 5 minutes followed by the i.v. infusion of argatroban at 20 μg/kg/min until the end of the procedure in Centre 02.
|
|---|---|---|
|
Mean Difference in QTc Interval Between ECG-2 and ECG-1 (ITT Population/Subgroup Male or Female)
|
-5.8936 milliseconds
Standard Deviation 46.4072
|
25.1460 milliseconds
Standard Deviation 39.0616
|
PRIMARY outcome
Timeframe: ECG-2 was recorded immediately after cardiac intervention when patient was fully anticoagulated with argatroban and ECG-1 was recorded at baseline prior to first bolus dose of argatroban (argatroban-free status).It was investigated if a mean QTc prolongation of more than 10 ms occurred between ECG-2 and ECG-1
Outcome measures
| Measure |
Argatroban Intravenous (i.v.) Bolus & i.v. Infusion (ITT Population/Centre 01)
n=25 Participants
i.v. bolus of 300 μg/kg argatroban administered over a span of 3 to 5 minutes followed by the i.v. infusion of argatroban at 20 μg/kg/min until the end of the procedure in Centre 01.
|
Argatroban Intravenous (i.v.) Bolus & i.v. Infusion (ITT Population/Centre 02)
n=25 Participants
i.v. bolus of 300 μg/kg argatroban administered over a span of 3 to 5 minutes followed by the i.v. infusion of argatroban at 20 μg/kg/min until the end of the procedure in Centre 02.
|
|---|---|---|
|
Mean Difference in QTc Interval Between ECG-2 and ECG-1 (ITT Population/Centre 01 or Centre 02)
|
15.0046 milliseconds
Standard Deviation 44.9538
|
-13.1343 milliseconds
Standard Deviation 44.2363
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SECONDARY outcome
Timeframe: ECG-2 immediately after argatroban infusionNumber of patients of ITT population exhibiting QTc interval of \> 500 ms
Outcome measures
| Measure |
Argatroban Intravenous (i.v.) Bolus & i.v. Infusion (ITT Population/Centre 01)
n=50 Participants
i.v. bolus of 300 μg/kg argatroban administered over a span of 3 to 5 minutes followed by the i.v. infusion of argatroban at 20 μg/kg/min until the end of the procedure in Centre 01.
|
Argatroban Intravenous (i.v.) Bolus & i.v. Infusion (ITT Population/Centre 02)
i.v. bolus of 300 μg/kg argatroban administered over a span of 3 to 5 minutes followed by the i.v. infusion of argatroban at 20 μg/kg/min until the end of the procedure in Centre 02.
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|---|---|---|
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Proportion of Patients With a Prolongation of QTc Interval to >500 ms at ECG-2
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1 Participants
|
—
|
Adverse Events
Argatroban Intravenous (i.v.) Bolus & i.v. Infusion
Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Argatroban Intravenous (i.v.) Bolus & i.v. Infusion
n=50 participants at risk
i.v. bolus of 300 μg/kg argatroban administered over a span of 3 to 5 minutes followed by the i.v. infusion of argatroban at 20 μg/kg/min until the end of the procedure.
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|---|---|
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Vascular disorders
Vascular stent thrombosis
|
4.0%
2/50 • i.v. bolus of 300 μg/kg argatroban administered over a span of 3 to 5 minutes followed by the i.v. infusion of argatroban at 20 μg/kg/min until the end of the procedure.
All AEs encountered during the clinical study will be reported on the AE page of the CRF.
|
|
Cardiac disorders
Acute myocardial infarction
|
6.0%
3/50 • i.v. bolus of 300 μg/kg argatroban administered over a span of 3 to 5 minutes followed by the i.v. infusion of argatroban at 20 μg/kg/min until the end of the procedure.
All AEs encountered during the clinical study will be reported on the AE page of the CRF.
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
2.0%
1/50 • i.v. bolus of 300 μg/kg argatroban administered over a span of 3 to 5 minutes followed by the i.v. infusion of argatroban at 20 μg/kg/min until the end of the procedure.
All AEs encountered during the clinical study will be reported on the AE page of the CRF.
|
Other adverse events
| Measure |
Argatroban Intravenous (i.v.) Bolus & i.v. Infusion
n=50 participants at risk
i.v. bolus of 300 μg/kg argatroban administered over a span of 3 to 5 minutes followed by the i.v. infusion of argatroban at 20 μg/kg/min until the end of the procedure.
|
|---|---|
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Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.0%
1/50 • i.v. bolus of 300 μg/kg argatroban administered over a span of 3 to 5 minutes followed by the i.v. infusion of argatroban at 20 μg/kg/min until the end of the procedure.
All AEs encountered during the clinical study will be reported on the AE page of the CRF.
|
|
Cardiac disorders
Sinus bradycardia
|
2.0%
1/50 • i.v. bolus of 300 μg/kg argatroban administered over a span of 3 to 5 minutes followed by the i.v. infusion of argatroban at 20 μg/kg/min until the end of the procedure.
All AEs encountered during the clinical study will be reported on the AE page of the CRF.
|
|
Blood and lymphatic system disorders
Hypertension
|
2.0%
1/50 • i.v. bolus of 300 μg/kg argatroban administered over a span of 3 to 5 minutes followed by the i.v. infusion of argatroban at 20 μg/kg/min until the end of the procedure.
All AEs encountered during the clinical study will be reported on the AE page of the CRF.
|
|
Investigations
Electrocardiogram ST segment depression
|
2.0%
1/50 • i.v. bolus of 300 μg/kg argatroban administered over a span of 3 to 5 minutes followed by the i.v. infusion of argatroban at 20 μg/kg/min until the end of the procedure.
All AEs encountered during the clinical study will be reported on the AE page of the CRF.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER