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

NCT00508924 | Completed Phase 2 Results

• 1 other identifier: ARG-E04
• Study Type: interventional
• Target: 140
• Locations: 2 countries
• Sites: 8

Brief Summary

This is a phase II multi-centre study in 140 patients undergoing elective PCI to obtain the information on dose-response of argatroban in pharmacodynamic markers and to assess the anticoagulation, safety and efficacy of argatroban in reference to unfractionated heparin, in combination with dual antiplatelet therapy.

Conditions

Coronary Artery Disease; Angina, Unstable

Keywords

Argatroban; Direct thrombin inhibitor; Percutaneous coronary intervention; Activated clotting time; PCI; ACT

Outcome Measures

Primary Outcomes (2)

• Activated Clotting Time (ACT) Value After the First Dosing of Study Treatment.

  5 - 10 min after initial bolus

• Composite and Each of Death, Myocardial Infarction, and Urgent Revascularisation at Day 30, and Major Bleeding Events During Hospital Stay.

  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

  30 Days

Study Arms (4)

ARG250

EXPERIMENTAL

Drug: Argatroban

ARG300

EXPERIMENTAL

Drug: Argatroban

ARG350

EXPERIMENTAL

Drug: Argatroban

Heparin

PLACEBO COMPARATOR

Drug: Heparin

Interventions

Argatroban DRUG

ARG250

Heparin DRUG

Heparin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female (women of child bearing potential must have a negative pregnancy test prior to entry into the study)
• Aged over 18 years
• Diagnosis of stable coronary artery disease (CAD) or unstable angina (troponin negative, i.e. within the normal range for the study site) with low to moderate anatomic risk and a requirement for elective percutaneous coronary angioplasty or stent insertion with an approved device in one or more de novo-treated or re-stenotic lesions in native vessels
• Signed written informed consent

You may not qualify if:

• Any condition which, in the investigator's opinion, contraindicates the use of argatroban, heparin or clopidogrel or endangers the patient if he/she participated in this study.
• Known cirrhosis, hepatitis, clinically significant hepatic disorder, or history of hepatic disorder. Hepatic disorder is defined as having levels of liver function tests (bilirubin, Aspartate Aminotransferase (Serum Glutamate Oxaloacetate Transaminase)(AST (SGOT)), Alanine Aminotransferase (Serum Glutamate Pyruvate Transaminase)(ALT (SGPT)) greater than 3.0 times above the upper limit of the normal range of local laboratory.
• Patients not currently taking aspirin
• Renal insufficiency, defined as serum creatinine greater than 2.0 mg/dL (greater than 177mmol/L)
• Platelets less than 125,000/ml
• If already taking any form of heparin prior to study enrolment, Activated Partial Thromboplastin Time(aPTT) equal or greater than 35 sec or ACT greater than 160 sec
• Use of low molecular heparin (LMWH) during 12 h prior to PCI
• If taking oral anticoagulant medication prior to study enrolment, International Normalised Ratio(INR) greater than 1.2
• Q wave MI with cardiogenic shock or thrombolytic therapy within 72 h of study dosing
• Use of Glycoprotein IIb / IIIa(GPIIb/IIIa) inhibitors within prior 3 weeks
• Documented coagulation disorder or bleeding diathesis
• Lumbar puncture within the past 2 weeks
• History of previous cerebral aneurysm, haemorrhagic stroke, or thrombotic stroke within the past 6 months
• Active, uncontrolled peptic ulcer disease or any gastrointestinal bleeding or genitourinary bleeding within 3 months prior to study enrolment
• Major surgery, serious trauma, puncture of non-compressible vessel, or biopsy of parenchymal organ within prior 2 months

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (8)

Unknown Facility

Aalst, Belgium

Location

Unknown Facility

Bad Nauheim, Germany

Location

Unknown Facility

Cologne, Germany

Location

Unknown Facility

Dachau, Germany

Location

Unknown Facility

Düren, Germany

Location

Unknown Facility

Frankfurt, Germany

Location

Unknown Facility

Halle, Germany

Location

Unknown Facility

Mainz, Germany

Location

Related Publications (1)

• Rossig L, Genth-Zotz S, Rau M, Heyndrickx GR, Schneider T, Gulba DC, Desaga M, Buerke M, Harder S, Zeiher AM; ARG-E04 study group. Argatroban for elective percutaneous coronary intervention: the ARG-E04 multi-center study. Int J Cardiol. 2011 Apr 14;148(2):214-9. doi: 10.1016/j.ijcard.2010.02.044. Epub 2010 Mar 11.

  PMID: 20226548 RESULT

MeSH Terms

Conditions

Coronary Artery Disease; Angina, Unstable

Interventions

argatroban; Heparin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Clinical Trials, Information Desk
• Organization: Tanabe Pharma Corporation

cti-inq-ml.JP@ml.tanabe-pharma.com

Study Officials

• Professor

  Information at Mitsubishi Pharma Europe

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 26, 2007
• First Posted: July 30, 2007
• Study Start: August 1, 2005
• Study Completion: October 1, 2006
• Last Updated: January 6, 2026
• Results First Posted: December 5, 2012

Record last verified: 2025-12

Locations

DE (7); BE (1)