Trial Outcomes & Findings for Study on Safety and Effectiveness of Three Doses of Argatroban as Anticoagulant in Percutaneous Coronary Intervention (PCI) (NCT NCT00508924)
NCT ID: NCT00508924
Last Updated: 2012-12-05
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
140 participants
Primary outcome timeframe
5 - 10 min after initial bolus
Results posted on
2012-12-05
Participant Flow
Participant milestones
| Measure |
ARG250
250μg/kg i.v. bolus of argatroban followed by infusion of 15μg/kg/min
additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec
|
ARG300
300μg/kg i.v. bolus followed by infusion of 20μg/kg/min
additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec
|
ARG350
350μg/kg i.v. bolus followed by infusion of 25μg/kg/min
additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec
|
Heparin
70-100 IU/kg i.v. bolus
additional 2,000-5,000 IU boluses could be given in order to reach the target ACT level of 250 sec
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
36
|
38
|
32
|
34
|
|
Overall Study
COMPLETED
|
36
|
38
|
31
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
ARG250
250μg/kg i.v. bolus of argatroban followed by infusion of 15μg/kg/min
additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec
|
ARG300
300μg/kg i.v. bolus followed by infusion of 20μg/kg/min
additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec
|
ARG350
350μg/kg i.v. bolus followed by infusion of 25μg/kg/min
additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec
|
Heparin
70-100 IU/kg i.v. bolus
additional 2,000-5,000 IU boluses could be given in order to reach the target ACT level of 250 sec
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Study on Safety and Effectiveness of Three Doses of Argatroban as Anticoagulant in Percutaneous Coronary Intervention (PCI)
Baseline characteristics by cohort
| Measure |
ARG250
n=36 Participants
250μg/kg i.v. bolus of argatroban followed by infusion of 15μg/kg/min
additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec
|
ARG300
n=38 Participants
300μg/kg i.v. bolus followed by infusion of 20μg/kg/min
additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec
|
ARG350
n=32 Participants
350μg/kg i.v. bolus followed by infusion of 25μg/kg/min
additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec
|
Heparin
n=34 Participants
70-100 IU/kg i.v. bolus
additional 2,000-5,000 IU boluses could be given in order to reach the target ACT level of 250 sec
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
63.4 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
65.5 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
68.3 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
65.9 years
STANDARD_DEVIATION 9.8 • n=4 Participants
|
65.7 years
STANDARD_DEVIATION 9.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
107 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 5 - 10 min after initial bolusOutcome measures
| Measure |
ARG250
n=36 Participants
250μg/kg i.v. bolus of argatroban followed by infusion of 15μg/kg/min
additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec
|
ARG300
n=38 Participants
300μg/kg i.v. bolus followed by infusion of 20μg/kg/min
additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec
|
ARG350
n=31 Participants
350μg/kg i.v. bolus followed by infusion of 25μg/kg/min
additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec
|
Heparin
n=33 Participants
70-100 IU/kg i.v. bolus
additional 2,000-5,000 IU boluses could be given in order to reach the target ACT level of 250 sec
|
|---|---|---|---|---|
|
Activated Clotting Time (ACT) Value After the First Dosing of Study Treatment.
|
301.0 second
Interval 262.8 to 330.0
|
330.0 second
Interval 270.0 to 365.0
|
354.0 second
Interval 307.0 to 391.0
|
237.5 second
Interval 198.0 to 284.0
|
PRIMARY outcome
Timeframe: 30 DaysComposite end point (a): all cause death, myocardial infarction and urgent revascularization at Day30 Composite end point (b): all cause death, myocardial infarction and urgent revascularization at Day30 as well as major bleeding events during hospital stay
Outcome measures
| Measure |
ARG250
n=36 Participants
250μg/kg i.v. bolus of argatroban followed by infusion of 15μg/kg/min
additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec
|
ARG300
n=38 Participants
300μg/kg i.v. bolus followed by infusion of 20μg/kg/min
additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec
|
ARG350
n=31 Participants
350μg/kg i.v. bolus followed by infusion of 25μg/kg/min
additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec
|
Heparin
n=33 Participants
70-100 IU/kg i.v. bolus
additional 2,000-5,000 IU boluses could be given in order to reach the target ACT level of 250 sec
|
|---|---|---|---|---|
|
Composite and Each of Death, Myocardial Infarction, and Urgent Revascularisation at Day 30, and Major Bleeding Events During Hospital Stay.
Composite end point (a)
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Composite and Each of Death, Myocardial Infarction, and Urgent Revascularisation at Day 30, and Major Bleeding Events During Hospital Stay.
Composite end point (b)
|
1 participants
|
0 participants
|
1 participants
|
2 participants
|
|
Composite and Each of Death, Myocardial Infarction, and Urgent Revascularisation at Day 30, and Major Bleeding Events During Hospital Stay.
All cause death
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Composite and Each of Death, Myocardial Infarction, and Urgent Revascularisation at Day 30, and Major Bleeding Events During Hospital Stay.
Myocardial infarction
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Composite and Each of Death, Myocardial Infarction, and Urgent Revascularisation at Day 30, and Major Bleeding Events During Hospital Stay.
Urgent revascularization
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Composite and Each of Death, Myocardial Infarction, and Urgent Revascularisation at Day 30, and Major Bleeding Events During Hospital Stay.
Major bleeding
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
Adverse Events
ARG250
Serious events: 4 serious events
Other events: 22 other events
Deaths: 0 deaths
ARG300
Serious events: 5 serious events
Other events: 25 other events
Deaths: 0 deaths
ARG350
Serious events: 7 serious events
Other events: 23 other events
Deaths: 0 deaths
Heparin
Serious events: 4 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ARG250
n=36 participants at risk
250μg/kg i.v. bolus of argatroban followed by infusion of 15μg/kg/min
additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec
|
ARG300
n=38 participants at risk
300μg/kg i.v. bolus followed by infusion of 20μg/kg/min
additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec
|
ARG350
n=32 participants at risk
350μg/kg i.v. bolus followed by infusion of 25μg/kg/min
additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec
|
Heparin
n=34 participants at risk
70-100 IU/kg i.v. bolus
additional 2,000-5,000 IU boluses could be given in order to reach the target ACT level of 250 sec
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/36
|
0.00%
0/38
|
0.00%
0/32
|
2.9%
1/34
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/36
|
0.00%
0/38
|
0.00%
0/32
|
2.9%
1/34
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/36
|
2.6%
1/38
|
0.00%
0/32
|
0.00%
0/34
|
|
Cardiac disorders
Angina unstable
|
2.8%
1/36
|
0.00%
0/38
|
0.00%
0/32
|
0.00%
0/34
|
|
Cardiac disorders
Artrial fibrillation
|
2.8%
1/36
|
0.00%
0/38
|
0.00%
0/32
|
0.00%
0/34
|
|
Cardiac disorders
Coronary artery dissection
|
0.00%
0/36
|
0.00%
0/38
|
3.1%
1/32
|
0.00%
0/34
|
|
Cardiac disorders
Coronary artery occlusion
|
2.8%
1/36
|
0.00%
0/38
|
0.00%
0/32
|
0.00%
0/34
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/36
|
0.00%
0/38
|
3.1%
1/32
|
0.00%
0/34
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/36
|
0.00%
0/38
|
3.1%
1/32
|
0.00%
0/34
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/36
|
0.00%
0/38
|
0.00%
0/32
|
2.9%
1/34
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/36
|
0.00%
0/38
|
3.1%
1/32
|
0.00%
0/34
|
|
General disorders
Chest pain
|
0.00%
0/36
|
2.6%
1/38
|
3.1%
1/32
|
0.00%
0/34
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/36
|
2.6%
1/38
|
0.00%
0/32
|
0.00%
0/34
|
|
Infections and infestations
Groin infection
|
0.00%
0/36
|
0.00%
0/38
|
0.00%
0/32
|
2.9%
1/34
|
|
Infections and infestations
Pneumonia
|
0.00%
0/36
|
0.00%
0/38
|
0.00%
0/32
|
2.9%
1/34
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
2.8%
1/36
|
0.00%
0/38
|
0.00%
0/32
|
0.00%
0/34
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/36
|
2.6%
1/38
|
0.00%
0/32
|
0.00%
0/34
|
|
Nervous system disorders
Basilar migraine
|
0.00%
0/36
|
0.00%
0/38
|
3.1%
1/32
|
0.00%
0/34
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/36
|
2.6%
1/38
|
0.00%
0/32
|
0.00%
0/34
|
|
Nervous system disorders
Syncope
|
0.00%
0/36
|
0.00%
0/38
|
3.1%
1/32
|
0.00%
0/34
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/36
|
2.6%
1/38
|
0.00%
0/32
|
0.00%
0/34
|
|
Vascular disorders
Peripheral ischaemia
|
2.8%
1/36
|
0.00%
0/38
|
0.00%
0/32
|
0.00%
0/34
|
Other adverse events
| Measure |
ARG250
n=36 participants at risk
250μg/kg i.v. bolus of argatroban followed by infusion of 15μg/kg/min
additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec
|
ARG300
n=38 participants at risk
300μg/kg i.v. bolus followed by infusion of 20μg/kg/min
additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec
|
ARG350
n=32 participants at risk
350μg/kg i.v. bolus followed by infusion of 25μg/kg/min
additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec
|
Heparin
n=34 participants at risk
70-100 IU/kg i.v. bolus
additional 2,000-5,000 IU boluses could be given in order to reach the target ACT level of 250 sec
|
|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
5.6%
2/36
|
7.9%
3/38
|
12.5%
4/32
|
11.8%
4/34
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/36
|
0.00%
0/38
|
0.00%
0/32
|
8.8%
3/34
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/36
|
0.00%
0/38
|
6.2%
2/32
|
0.00%
0/34
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/36
|
7.9%
3/38
|
6.2%
2/32
|
2.9%
1/34
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/36
|
5.3%
2/38
|
3.1%
1/32
|
0.00%
0/34
|
|
Gastrointestinal disorders
Nausea
|
2.8%
1/36
|
7.9%
3/38
|
9.4%
3/32
|
11.8%
4/34
|
|
General disorders
Catheter site haematoma
|
33.3%
12/36
|
23.7%
9/38
|
28.1%
9/32
|
29.4%
10/34
|
|
General disorders
Catheter site haemorrhage
|
8.3%
3/36
|
0.00%
0/38
|
9.4%
3/32
|
5.9%
2/34
|
|
General disorders
Catheter site pain
|
0.00%
0/36
|
0.00%
0/38
|
0.00%
0/32
|
5.9%
2/34
|
|
General disorders
Chest pain
|
0.00%
0/36
|
5.3%
2/38
|
3.1%
1/32
|
8.8%
3/34
|
|
General disorders
Pyrexia
|
0.00%
0/36
|
0.00%
0/38
|
0.00%
0/32
|
5.9%
2/34
|
|
Investigations
Cardiac enzymes increased
|
8.3%
3/36
|
2.6%
1/38
|
3.1%
1/32
|
0.00%
0/34
|
|
Investigations
Haematocrit decreased
|
0.00%
0/36
|
2.6%
1/38
|
3.1%
1/32
|
8.8%
3/34
|
|
Investigations
Haemoglobin decreased
|
2.8%
1/36
|
2.6%
1/38
|
6.2%
2/32
|
8.8%
3/34
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/36
|
0.00%
0/38
|
3.1%
1/32
|
8.8%
3/34
|
|
Investigations
Troponin T increased
|
5.6%
2/36
|
5.3%
2/38
|
0.00%
0/32
|
0.00%
0/34
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/36
|
0.00%
0/38
|
0.00%
0/32
|
5.9%
2/34
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/36
|
0.00%
0/38
|
6.2%
2/32
|
0.00%
0/34
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.8%
1/36
|
0.00%
0/38
|
0.00%
0/32
|
8.8%
3/34
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
2/36
|
2.6%
1/38
|
9.4%
3/32
|
11.8%
4/34
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.8%
1/36
|
5.3%
2/38
|
0.00%
0/32
|
0.00%
0/34
|
|
Nervous system disorders
Headache
|
2.8%
1/36
|
2.6%
1/38
|
6.2%
2/32
|
0.00%
0/34
|
|
Nervous system disorders
Syncope vasovagal
|
8.3%
3/36
|
2.6%
1/38
|
0.00%
0/32
|
2.9%
1/34
|
|
Psychiatric disorders
Agitation
|
2.8%
1/36
|
0.00%
0/38
|
0.00%
0/32
|
5.9%
2/34
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.8%
1/36
|
0.00%
0/38
|
6.2%
2/32
|
0.00%
0/34
|
|
Vascular disorders
Hypertension
|
0.00%
0/36
|
10.5%
4/38
|
6.2%
2/32
|
14.7%
5/34
|
|
Vascular disorders
Hypotension
|
8.3%
3/36
|
5.3%
2/38
|
12.5%
4/32
|
14.7%
5/34
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER