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Argatroban (Argatroban) - Summary

 
 



ARGATROBAN SUMMARY

Argatroban is a synthetic direct thrombin inhibitor derived from L-arginine. The chemical name for Argatroban is 1-[5-[(aminoiminomethyl)amino]-1-oxo-2-[[(1,2,3,4-tetrahydro-3-methyl- 8-quinolinyl)sulfonyl]amino]pentyl]-4-methyl-2-piperidinecarboxylic acid, monohydrate. Argatroban has 4 asymmetric carbons. One of the asymmetric carbons has an R configuration (stereoisomer Type I) and an S configuration (stereoisomer Type II). Argatroban consists of a mixture of R and S stereoisomers at a ratio of approximately 65:35.

Argatroban is indicated as an anticoagulant for prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia.

Argatroban is indicated as an anticoagulant in patients with or at risk for heparin-induced thrombocytopenia undergoing percutaneous coronary intervention (PCI).


See all Argatroban indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Argatroban

Anticoagulation with argatroban for elective percutaneous coronary intervention: population pharmacokinetics and pharmacokinetic-pharmacodynamic relationship of coagulation parameters. [2011.06]
The synthetic direct thrombin inhibitor argatroban has a rapid onset and offset of anticoagulation. However, there are no data about the pharmacokinetic-pharmacodynamic (PK-PD) relationship of argatroban in patients undergoing contemporary percutaneous coronary intervention (PCI) and no data about other coagulation parameters than activated clotting time (ACT) in this setting...

Argatroban for elective percutaneous coronary intervention: the ARG-E04 multi-center study. [2011.04.14]
CONCLUSION: Argatroban dose-dependently increases coagulation parameters and, compared to UFH, demonstrates a superior predictable anticoagulant effect in patients undergoing elective PCI. Copyright (c) 2010. Published by Elsevier Ireland Ltd.

Rationale and design of the PREVENT-HIT study: a randomized, open-label pilot study to compare desirudin and argatroban in patients with suspected heparin-induced thrombocytopenia with or without thrombosis. [2010.04]
CONCLUSION: The results from the PREVENT-HIT study should enhance understanding of the comparative clinical and economic utility of desirudin and argatroban in patients with HIT with or without thrombosis. ClinicalTrials.gov identifier: NCT00787332.

Platelet activity, coagulation, and fibrinolysis during exercise in healthy males: effects of thrombin inhibition by argatroban and enoxaparin. [2007.02]
CONCLUSIONS: Strenuous exercise enhances platelet and leukocyte activation independently of thrombin. Exercise augments both coagulation and fibrinolysis, but the balance between them appears to be maintained. At therapeutic dosages argatroban counteracted thrombin-induced platelet activation most efficiently, whereas enoxaparin had somewhat stronger anticoagulant and profibrinolytic effects.

A prospective comparison of three argatroban treatment regimens during hemodialysis in end-stage renal disease. [2004.12]
BACKGROUND: We prospectively evaluated 3 treatment regimens of argatroban, a direct thrombin inhibitor, for providing adequate, safe anticoagulation in patients with end-stage renal disease (ESRD) during hemodialysis... CONCLUSION: Argatroban, administered by each treatment regimen, provides safe, adequate anticoagulation to enable successful hemodialysis in ESRD patients. Argatroban dialytic clearance by high-flux membranes is clinically insignificant.

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Clinical Trials Related to Argatroban

Randomized Controlled Trial of Argatroban With tPA for Acute Stroke [Recruiting]
Randomized controlled clinical trial to estimate overall treatment benefit (improvement in disability) among stroke patients treated with rt-PA who are randomized to also receive either low-dose Argatroban, high-dose Argatroban or neither.

Argatroban for Preventing Occlusion and Restenosis After Intracranial and Extracranial Artery Stenting [Recruiting]
Argatroban is a selective thrombin inhibitor, and previous study had suggested that argatroban use post PCI could potentially prevent reocclusion. But there has no study on large sample of argatroban treated restenosis post cranial stenting. This study will test the safety and efficacy of the argatroban on prevent occlusion and restenosis in patients with intracranial and extracranial artery stenting.

Argatroban Versus Lepirudin in Critically Ill Patients [Recruiting]

Argatroban in Critically Ill Patients With Heparin Resistance [Recruiting]
Critically ill patients with high risk for thrombosis or tromboembolic events with the presence of heparin resistance, treated at the Department for General and Surgical Critical Care Medicine of the Medical University Innsbruck, Austria will be enrolled in the study when meeting the inclusion- and exclusion criteria. If a patient meets the inclusion criteria and is recruited for the study, the patient will be randomized either to Group A or Group H.

All patients have to achieve a prophylactic aPTT-target range of an aPTT-level of 45 - 60

sec (Pathromtin® SL) within 6 to 8 hours.

Randomisation Group A:

If a Heparin resistance appears and the patient meets the inclusion and exclu-sion criteria, he/she will be enrolled. The Heparin administration will be stopped and Argatroban will be given and adjusted until the target aPTT-range is achieved.

Randomisation Group H - Standard therapy:

If a Heparin resistance appears and the patient meets the inclusion and exclu-sion criteria, he/she will be enrolled. The Heparin administration will be contin-ued and, if necessary increased. Hereby the maximum heparin dose is 1. 500 IU per hour.

Therapy failure Group H:

Primary target failure at Visit 3 (6-8 hours):

If a patient of Group H does not achieve the target-aPTT within 6-8 hours, he/she will switch to Group A and will start with T1 (Baseline) and will follow the visits according to Group A until the final Visit 12 (T1 / day 30).

Maintenance failure after Visit 3:

Maintenance failure after 6-8 hours is defined as non-maintenance of the tar-get-aPTT until day 7 with a max. heparin dosage of 1. 500 IU per hour. In this case, heparin therapy has to be changed to Argatroban.

The patient will start with T1 (Baseline) and will follow the visits according to Group A until the final Visit 12 (day 30) counting from the Baseline of Group A.

Therapy failure Group A:

If a patient of Group A does not achieve the target-aPTT within 6-8 hours or cannot maintain the target-aPTT in spite of 3 more adjustements during the further study period, the patient automatically drops out of the study.

The same is effective for patients who switched to the Group A after a therapy failure in Group H.

General:

Two hours after starting the Baseline investigations, patient's parameters in-cluding blood collections will be measured for the second time (T2). Additional measurements will be made at 6 hours (T3), 24 hours (T4), 48 hours (T5), 3 days (T6), 4 days (T7), 5 days (T8), 6 days (T9) and 7 days (T10) after Baseline and 6 h after study medication stop (T11). 30 days after inclusion in the study, a final investigation is planned (T12).

Argatroban TPA Stroke Study [Recruiting]
Is the combination of low doses of argatroban in combination with rt-PA safe, and does it increase recanalization in patients with acute ischemic stroke.

more trials >>

Reports of Suspected Argatroban Side Effects

Cerebral Infarction (10)Prothrombin Time Shortened (10)Hepatic Function Abnormal (9)Haemorrhage (9)International Normalised Ratio Increased (8)Pulmonary Alveolar Haemorrhage (8)Gastrointestinal Haemorrhage (7)Pyrexia (7)Activated Partial Thromboplastin Time Prolonged (7)Pneumonia (7)more >>


Page last updated: 2011-12-09

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