Trial Outcomes & Findings for A Comparative Sudy Comparing Argatroban® IV vs Desirudin SC for Suspected HIT With or Without Thrombosis Syndrome (NCT NCT00787332)
NCT ID: NCT00787332
Last Updated: 2013-01-10
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
16 participants
Primary outcome timeframe
30 days
Results posted on
2013-01-10
Participant Flow
Patients were enrolled between November 2008 and December 2009 from approximately 20 US Medical Centers
Patients were excluded if they had severe renal failure (CrCL\<30 mL/min), known allergy to r-hirudins or argatroban, multisystem organ failure, uncontrolled bleeding.
Participant milestones
| Measure |
Desirudin
Patients with suspected HIT randomized to SC Desirudin in a 1:1 ratio
|
Argatroban®
Patients with suspected HIT randomized to IV Argatroban® in a 1:1 ratio
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Comparative Sudy Comparing Argatroban® IV vs Desirudin SC for Suspected HIT With or Without Thrombosis Syndrome
Baseline characteristics by cohort
| Measure |
Desirudin
n=8 Participants
Patients with suspected HIT randomized to SC Desirudin i
|
Argatroban®
n=8 Participants
Patients with suspected HIT randomized to IV Argatroban®
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=113 Participants
|
6 Participants
n=163 Participants
|
12 Participants
n=160 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=113 Participants
|
2 Participants
n=163 Participants
|
4 Participants
n=160 Participants
|
|
Age Continuous
|
69 years
STANDARD_DEVIATION 9.5 • n=113 Participants
|
62 years
STANDARD_DEVIATION 9.3 • n=163 Participants
|
65 years
STANDARD_DEVIATION 9 • n=160 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=113 Participants
|
3 Participants
n=163 Participants
|
6 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=113 Participants
|
5 Participants
n=163 Participants
|
10 Participants
n=160 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=113 Participants
|
8 participants
n=163 Participants
|
16 participants
n=160 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: All patients receiving drug
Outcome measures
| Measure |
Desirudin
n=8 Participants
Patients with suspected HIT randomized to SC Desirudin in a 1:1 ratio
|
Argatroban®
n=8 Participants
Patients with suspected HIT randomized to IV Argatroban® in a 1:1 ratio
|
|---|---|---|
|
New Thrombosis, Amputation, Death, Major and Minor Bleeding
|
1 participants
|
5 participants
|
Adverse Events
Desirudin
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Argatroban®
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Desirudin
n=8 participants at risk
Patients with suspected HIT randomized to SC Desirudin i
|
Argatroban®
n=8 participants at risk
Patients with suspected HIT randomized to IV Argatroban®
|
|---|---|---|
|
Gastrointestinal disorders
esophageal hematoma
|
0.00%
0/8 • 30 days
|
12.5%
1/8 • Number of events 1 • 30 days
|
|
Gastrointestinal disorders
Sublingual Hematoma
|
12.5%
1/8 • Number of events 1 • 30 days
|
0.00%
0/8 • 30 days
|
|
Vascular disorders
femoral graft thrombosis
|
0.00%
0/8 • 30 days
|
12.5%
1/8 • Number of events 1 • 30 days
|
Other adverse events
| Measure |
Desirudin
n=8 participants at risk
Patients with suspected HIT randomized to SC Desirudin i
|
Argatroban®
n=8 participants at risk
Patients with suspected HIT randomized to IV Argatroban®
|
|---|---|---|
|
Blood and lymphatic system disorders
leukocytosis
|
0.00%
0/8 • 30 days
|
25.0%
2/8 • Number of events 2 • 30 days
|
|
Metabolism and nutrition disorders
hypoglycemia
|
0.00%
0/8 • 30 days
|
12.5%
1/8 • Number of events 1 • 30 days
|
|
Gastrointestinal disorders
dysphagia
|
0.00%
0/8 • 30 days
|
12.5%
1/8 • Number of events 1 • 30 days
|
|
Cardiac disorders
non-sustained ventricular tachycardia
|
0.00%
0/8 • 30 days
|
12.5%
1/8 • Number of events 1 • 30 days
|
|
Vascular disorders
right groin hematoma
|
0.00%
0/8 • 30 days
|
12.5%
1/8 • Number of events 1 • 30 days
|
|
Nervous system disorders
anxiety
|
12.5%
1/8 • Number of events 1 • 30 days
|
0.00%
0/8 • 30 days
|
|
Cardiac disorders
sinus tachycardia
|
12.5%
1/8 • Number of events 1 • 30 days
|
12.5%
1/8 • Number of events 1 • 30 days
|
|
Gastrointestinal disorders
elevated LFT's
|
25.0%
2/8 • Number of events 2 • 30 days
|
12.5%
1/8 • Number of events 1 • 30 days
|
|
Skin and subcutaneous tissue disorders
mild rash
|
12.5%
1/8 • Number of events 1 • 30 days
|
0.00%
0/8 • 30 days
|
|
Skin and subcutaneous tissue disorders
shingles
|
12.5%
1/8 • Number of events 1 • 30 days
|
0.00%
0/8 • 30 days
|
|
Infections and infestations
fever
|
12.5%
1/8 • Number of events 1 • 30 days
|
0.00%
0/8 • 30 days
|
|
Infections and infestations
clostridium difficile infection
|
12.5%
1/8 • Number of events 1 • 30 days
|
0.00%
0/8 • 30 days
|
|
Cardiac disorders
atrial fibrillation
|
12.5%
1/8 • Number of events 1 • 30 days
|
0.00%
0/8 • 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place