Coronary Artery DiseasePhase 2NCT00508924
Study on Safety and Effectiveness of Three Doses of Argatroban as Anticoagulant in Percutaneous Coronary Intervention (PCI)
A Phase 2 study testing Argatroban and Heparin in people with Coronary Artery Disease and Angina, Unstable, run by Tanabe Pharma Corporation at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Angina, Unstable
- What is being tested?
- Argatroban and Heparin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Aug 2005to Oct 2006
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 26Show fewer
- 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
- Planned staged procedure, planned rotational atherectomy, directional coronary atherectomy, brachytherapy, or thrombectomy catheters
- Planned surgical intervention other than study procedure within next 7 days
- Presence of greater than 50% stenosis of unprotected left main coronary artery
- Severe peripheral vascular disease, precluding femoral access
- History of vasculitis
- Uncontrolled hypertension defined as greater than 180/120 mmHg
- Pregnancy (exclusion by routine urine test)
- Lactating woman
- Woman of children bearing age who are or were not using accepted contraceptive methods
- Participation in other clinical trials of investigational products within 3 months prior to study enrolment
- Terminally ill patients with a life expectancy of < 3 months
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Germany7 sites
Study site
Bad Nauheim
Study site
Cologne
Study site
Dachau
Study site
Düren
Study site
Frankfurt
Study site
Halle
Study site
Mainz
About this study
Official title: A Randomised, Open, Parallel-group, Multicentre Study to Examine the Safety and Effectiveness of Three Doses of Argatroban as Anticoagulant in Combination With Clopidogrel and Aspirin in Patients Undergoing Elective Percutaneous Coronary Intervention in Comparison With Unfractionated Heparin, Clopidogrel and Aspirin
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.
Read the detailed description
This is a phase II multi-centre study in Europe in patients with stable coronary artery disease or troponin negative unstable angina undergoing elective PCI, to obtain the information on the safety and effects on various pharmacodynamic markers, of three doses of argatroban in combination with clopidogrel and aspirin, and to assess the results of argatroban and unfractionated heparin, both used in combination with clopidogrel and aspirin, on clinical outcomes, adequacy of anticoagulation, various pharmacodynamic markers (approximately 35 patients per group).
- Conditions
- Coronary Artery Disease, Angina, Unstable
- Being tested
- Argatroban, Heparin
- Keywords
- Argatroban, Direct thrombin inhibitor, Percutaneous coronary intervention, Activated clotting time, PCI, ACT
- Medical subject headings
- Coronary Artery Disease, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArgatrobanDrug
ArgatrobanDrug
ArgatrobanDrug
HeparinDrug
| Study group | Role | What they receive |
|---|---|---|
| ARG250 | Experimental | Not described Receives: Drug: Argatroban |
| ARG300 | Experimental | Not described Receives: Drug: Argatroban |
| ARG350 | Experimental | Not described Receives: Drug: Argatroban |
| Heparin | Placebo comparator | Not described Receives: Drug: Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activated Clotting Time (ACT) Value After the First Dosing of Study Treatment.
Measured: 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
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2007 (estimated)
- Study startAug 2005
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Professor, Principal investigator, Information at Mitsubishi Pharma Europe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00508924
- Sponsor's protocol ID
- ARG-E04
- Status last verified
- Dec 2025
- First submitted
- 26 Jul 2007
- Last updated
- 6 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 20226548
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Open, Parallel-group, Multicentre Study to Examine the Safety and Effectiveness of Three Doses of Argatroban as Anticoagulant in Combination With Clopidogrel and Aspirin in Patients Undergoing Elective Percutaneous Coronary Intervention in Comparison With Unfractionated Heparin, Clopidogrel and Aspirin
- ClinicalTrials.gov ID
- NCT00508924
- Acronym / sponsor ID
- ARG-E04
- Conditions
- Coronary Artery Disease, Angina, Unstable
- Keywords
- Argatroban, Direct thrombin inhibitor, Percutaneous coronary intervention, Activated clotting time, PCI, ACT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Study completion
- Oct 2006 (actual)
- First posted
- 30 Jul 2007 (estimated)
- Results
- Posted 5 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase II multi-centre study in Europe in patients with stable coronary artery disease or troponin negative unstable angina undergoing elective PCI, to obtain the information on the safety and effects on various pharmacodynamic markers, of three doses of argatroban in combination with clopidogrel and aspirin, and to assess the results of argatroban and unfractionated heparin, both used in combination with clopidogrel and aspirin, on clinical outcomes, adequacy of anticoagulation, various pharmacodynamic markers (approximately 35 patients per group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ARG250 | Experimental | Drug: Argatroban |
| ARG300 | Experimental | Drug: Argatroban |
| ARG350 | Experimental | Drug: Argatroban |
| Heparin | Placebo comparator | Drug: Heparin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Argatroban | Drug | ARG250 |
| Argatroban | Drug | ARG300 |
| Argatroban | Drug | ARG350 |
| Heparin | Drug | Heparin |
Primary outcome
Activated Clotting Time (ACT) Value After the First Dosing of Study Treatment.
Time frame: 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.
Time frame: 30 Days
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20226548Rossig 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Professor principal investigator
Information at Mitsubishi Pharma Europe
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Argatroban and Heparin in people with Coronary Artery Disease and Angina, Unstable, run by Tanabe Pharma Corporation at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activated Clotting Time (ACT) Value After the First Dosing of Study Treatment. (time frame: 5 - 10 min after initial bolus). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00508924, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.