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Trial record 87 of 172 for:    "Heart Disease" | "Heparin"

Study on Safety and Effectiveness of Three Doses of Argatroban as Anticoagulant in Percutaneous Coronary Intervention (PCI)

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ClinicalTrials.gov Identifier: NCT00508924
Recruitment Status : Completed
First Posted : July 30, 2007
Results First Posted : December 5, 2012
Last Update Posted : December 5, 2012
Sponsor:
Information provided by:
Mitsubishi Tanabe Pharma Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Coronary Artery Disease
Angina, Unstable
Interventions Drug: Argatroban
Drug: Heparin
Enrollment 140
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ARG250 ARG300 ARG350 Heparin
Hide Arm/Group Description

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

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

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

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

Period Title: Overall Study
Started 36 38 32 34
Completed 36 38 31 33
Not Completed 0 0 1 1
Reason Not Completed
Protocol Violation             0             0             1             1
Arm/Group Title ARG250 ARG300 ARG350 Heparin Total
Hide Arm/Group Description

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

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

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

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 of all reporting groups
Overall Number of Baseline Participants 36 38 32 34 140
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 38 participants 32 participants 34 participants 140 participants
63.4  (8.9) 65.5  (9.5) 68.3  (7.9) 65.9  (9.8) 65.7  (9.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 38 participants 32 participants 34 participants 140 participants
Female
11
  30.6%
8
  21.1%
9
  28.1%
5
  14.7%
33
  23.6%
Male
25
  69.4%
30
  78.9%
23
  71.9%
29
  85.3%
107
  76.4%
1.Primary Outcome
Title Activated Clotting Time (ACT) Value After the First Dosing of Study Treatment.
Hide Description [Not Specified]
Time Frame 5 - 10 min after initial bolus
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ARG250 ARG300 ARG350 Heparin
Hide Arm/Group Description:

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

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

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

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 Number of Participants Analyzed 36 38 31 33
Median (Inter-Quartile Range)
Unit of Measure: second
301.0
(262.8 to 330.0)
330.0
(270.0 to 365.0)
354.0
(307.0 to 391.0)
237.5
(198.0 to 284.0)
2.Primary Outcome
Title Composite and Each of Death, Myocardial Infarction, and Urgent Revascularisation at Day 30, and Major Bleeding Events During Hospital Stay.
Hide Description

Composite 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

Time Frame 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ARG250 ARG300 ARG350 Heparin
Hide Arm/Group Description:

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

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

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

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 Number of Participants Analyzed 36 38 31 33
Measure Type: Number
Unit of Measure: participants
Composite end point (a) 1 0 1 1
Composite end point (b) 1 0 1 2
All cause death 0 0 0 0
Myocardial infarction 0 0 1 1
Urgent revascularization 1 0 1 0
Major bleeding 0 0 0 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ARG250 ARG300 ARG350 Heparin
Hide Arm/Group Description

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

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

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

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

All-Cause Mortality
ARG250 ARG300 ARG350 Heparin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ARG250 ARG300 ARG350 Heparin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/36 (11.11%)   5/38 (13.16%)   7/32 (21.88%)   4/34 (11.76%) 
Blood and lymphatic system disorders         
Anaemia  0/36 (0.00%)  0/38 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Cardiac disorders         
Acute myocardial infarction  0/36 (0.00%)  0/38 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Angina pectoris  0/36 (0.00%)  1/38 (2.63%)  0/32 (0.00%)  0/34 (0.00%) 
Angina unstable  1/36 (2.78%)  0/38 (0.00%)  0/32 (0.00%)  0/34 (0.00%) 
Artrial fibrillation  1/36 (2.78%)  0/38 (0.00%)  0/32 (0.00%)  0/34 (0.00%) 
Coronary artery dissection  0/36 (0.00%)  0/38 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Coronary artery occlusion  1/36 (2.78%)  0/38 (0.00%)  0/32 (0.00%)  0/34 (0.00%) 
Myocardial infarction  0/36 (0.00%)  0/38 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Gastrointestinal disorders         
Abdominal pain upper  0/36 (0.00%)  0/38 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Retroperitoneal haematoma  0/36 (0.00%)  0/38 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
General disorders         
Catheter site haemorrhage  0/36 (0.00%)  0/38 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Chest pain  0/36 (0.00%)  1/38 (2.63%)  1/32 (3.13%)  0/34 (0.00%) 
Immune system disorders         
Hypersensitivity  0/36 (0.00%)  1/38 (2.63%)  0/32 (0.00%)  0/34 (0.00%) 
Infections and infestations         
Groin infection  0/36 (0.00%)  0/38 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Pneumonia  0/36 (0.00%)  0/38 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Injury, poisoning and procedural complications         
Lower limb fracture  1/36 (2.78%)  0/38 (0.00%)  0/32 (0.00%)  0/34 (0.00%) 
Musculoskeletal and connective tissue disorders         
Rhabdomyolysis  0/36 (0.00%)  1/38 (2.63%)  0/32 (0.00%)  0/34 (0.00%) 
Nervous system disorders         
Basilar migraine  0/36 (0.00%)  0/38 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Cerebrovascular accident  0/36 (0.00%)  1/38 (2.63%)  0/32 (0.00%)  0/34 (0.00%) 
Syncope  0/36 (0.00%)  0/38 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Psychiatric disorders         
Panic attack  0/36 (0.00%)  1/38 (2.63%)  0/32 (0.00%)  0/34 (0.00%) 
Vascular disorders         
Peripheral ischaemia  1/36 (2.78%)  0/38 (0.00%)  0/32 (0.00%)  0/34 (0.00%) 
1
Term from vocabulary, MedDRA 9.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ARG250 ARG300 ARG350 Heparin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   22/36 (61.11%)   25/38 (65.79%)   23/32 (71.88%)   27/34 (79.41%) 
Cardiac disorders         
Angina pectoris  2/36 (5.56%)  3/38 (7.89%)  4/32 (12.50%)  4/34 (11.76%) 
Bradycardia  0/36 (0.00%)  0/38 (0.00%)  0/32 (0.00%)  3/34 (8.82%) 
Sinus bradycardia  0/36 (0.00%)  0/38 (0.00%)  2/32 (6.25%)  0/34 (0.00%) 
Ear and labyrinth disorders         
Vertigo  0/36 (0.00%)  3/38 (7.89%)  2/32 (6.25%)  1/34 (2.94%) 
Gastrointestinal disorders         
Abdominal pain  0/36 (0.00%)  2/38 (5.26%)  1/32 (3.13%)  0/34 (0.00%) 
Nausea  1/36 (2.78%)  3/38 (7.89%)  3/32 (9.38%)  4/34 (11.76%) 
General disorders         
Catheter site haematoma  12/36 (33.33%)  9/38 (23.68%)  9/32 (28.13%)  10/34 (29.41%) 
Catheter site haemorrhage  3/36 (8.33%)  0/38 (0.00%)  3/32 (9.38%)  2/34 (5.88%) 
Catheter site pain  0/36 (0.00%)  0/38 (0.00%)  0/32 (0.00%)  2/34 (5.88%) 
Chest pain  0/36 (0.00%)  2/38 (5.26%)  1/32 (3.13%)  3/34 (8.82%) 
Pyrexia  0/36 (0.00%)  0/38 (0.00%)  0/32 (0.00%)  2/34 (5.88%) 
Investigations         
Cardiac enzymes increased  3/36 (8.33%)  1/38 (2.63%)  1/32 (3.13%)  0/34 (0.00%) 
Haematocrit decreased  0/36 (0.00%)  1/38 (2.63%)  1/32 (3.13%)  3/34 (8.82%) 
Haemoglobin decreased  1/36 (2.78%)  1/38 (2.63%)  2/32 (6.25%)  3/34 (8.82%) 
Red blood cell count decreased  0/36 (0.00%)  0/38 (0.00%)  1/32 (3.13%)  3/34 (8.82%) 
Troponin T increased  2/36 (5.56%)  2/38 (5.26%)  0/32 (0.00%)  0/34 (0.00%) 
Metabolism and nutrition disorders         
Hyperglycaemia  0/36 (0.00%)  0/38 (0.00%)  0/32 (0.00%)  2/34 (5.88%) 
Hyponatraemia  0/36 (0.00%)  0/38 (0.00%)  2/32 (6.25%)  0/34 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1/36 (2.78%)  0/38 (0.00%)  0/32 (0.00%)  3/34 (8.82%) 
Back pain  2/36 (5.56%)  1/38 (2.63%)  3/32 (9.38%)  4/34 (11.76%) 
Pain in extremity  1/36 (2.78%)  2/38 (5.26%)  0/32 (0.00%)  0/34 (0.00%) 
Nervous system disorders         
Headache  1/36 (2.78%)  1/38 (2.63%)  2/32 (6.25%)  0/34 (0.00%) 
Syncope vasovagal  3/36 (8.33%)  1/38 (2.63%)  0/32 (0.00%)  1/34 (2.94%) 
Psychiatric disorders         
Agitation  1/36 (2.78%)  0/38 (0.00%)  0/32 (0.00%)  2/34 (5.88%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1/36 (2.78%)  0/38 (0.00%)  2/32 (6.25%)  0/34 (0.00%) 
Vascular disorders         
Hypertension  0/36 (0.00%)  4/38 (10.53%)  2/32 (6.25%)  5/34 (14.71%) 
Hypotension  3/36 (8.33%)  2/38 (5.26%)  4/32 (12.50%)  5/34 (14.71%) 
1
Term from vocabulary, MedDRA 9.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trials, Information Desk
Organization: Mitsubishi Tanabe Pharma Corporation
EMail: cti-inq-ml@ml.mt-pharma.co.jp
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00508924     History of Changes
Other Study ID Numbers: ARG-E04
First Submitted: July 26, 2007
First Posted: July 30, 2007
Results First Submitted: November 6, 2012
Results First Posted: December 5, 2012
Last Update Posted: December 5, 2012