Stable Coronary Artery Disease (CAD)Phase 4SAICoDisNCT05740371
Safety of Argatroban Infusion in Conduction Disturbances
A Phase 4 study testing Argatroban in people with Stable Coronary Artery Disease (CAD) and Unstable Angina (Troponin Negative), run by Tanabe Pharma GmbH at 2 sites in Germany.
Trial summary
To determine change of QTc interval during intravenous argatroban infusion in patients undergoing percutaneous coronary intervention (PCI) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Coronary Artery Disease (CAD), Unstable Angina (Troponin Negative)
- What is being tested?
- Argatroban
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesGermany
- Study dates
- 18 Apr 2017to 6 May 2021
- Phase
- Phase 4
- 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
- Diagnosis of stable CAD or unstable angina (troponin negative, i.e. within the normal range for the study site) with low to moderate anatomic risk.
- Patient required 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.
- Patient was on adequate platelet inhibition therapy after having received a loading dose with ASA and clopidogrel before start of intervention (this additional inclusion criterion was introduced with study protocol version 1.6, dated 14.12.2018)
- Willingness to give written informed consent, written consent for data protection (legal requirement in Germany "datenschutzrechtliche Einwilligung") and willingness to participate and to comply with the requirements of the study protocol.
- The patient (female/male) was at least 18 years of age.
- Baseline ECG without changes that impair assessment of QTc interval.
Who cannot join
- Patient was indicated for highly complex 3-vessel intervention.
- The female patient was pregnant (exclusion by routine urine test) or was nursing during therapy period.
- Patients who were currently participating in another clinical trial or patients who participated in another clinical trial during the last 3 months prior to study start (date of treatment visit).
- History of drug, alcohol or chemical abuse within 6 months prior to study start.
- Planned surgical intervention other than study procedure within 7 days after study start.
- Any condition, which contraindicated the use of argatroban, or endangered the patient if he/she participated in this study.
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- Factors influencing QTc interval:
- Marked baseline prolongation of QTc interval (repeated demonstration of a QTc interval > 450 ms at baseline ECG).
- A history of risk factors of Torsade de pointes (e.g. heart failure, hypokalemia, family history of Long QT Syndrome).
- Known intraventricular conduction disturbance.
- Bradycardia: heart rate < 45 min-1.
- Electrolyte level outside normal range (according to laboratory's reference values).
- The use of concomitant medications that interfered with the QTc interval.
- Intake of digitalis within the last 2 weeks before study start.
- Acute myocardial infarction or troponin-positive unstable angina.
- Factors inhibiting use of argatroban in this study:
- Intolerance to ingredients of Argatra® (sorbitol).
- Known cirrhosis, hepatitis, clinically significant hepatic disorder at study start and/or history of clinically relevant hepatic disorder.
- Current hepatic disorder indicated by laboratory liver profile at screening: Bilirubin, AST/SGOT, ALT/SGPT, gammaGT > 3.0 times upper limit of the normal (ULN).
- Renal insufficiency indicated by laboratory renal profile at study start: GFR < 35 ml/min.
- Uncontrolled hypertension (defined as blood pressure >180/120 mmHg).
- If any form of heparin was taken prior to study start and aPTT ≥ 35 s.
- Intake of direct oral anticoagulants (DOAC) within 1 month prior to study start.
- If anticoagulants of type of vitamin K antagonists (VKA) were taken prior to study start and INR >1.2.
- Platelet count <125 x 109/l.
- Documented coagulation disorder or bleeding diathesis.
- Uncontrolled haemorrhage within the past 3 months.
- Uncontrolled peptic ulcer disease or gastrointestinal bleeding within the past 3 months.
- Cerebral aneurysm.
- Haemorrhagic stroke or ischaemic stroke in the past 6 months.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University Hospital Frankfurt
Frankfurt am Main, Hesse, 60590
Herz-Kreislauf-Zentrum Klinikum Hersfeld-Rotenburg
Rotenburg an der Fulda, Hesse, 36199
About this study
Official title: SAICoDis - Safety of Argatroban Infusion in Conduction Disturbances. A Prospective, Open, Multicenter Safety Study to Investigate Conduction Disturbances in Patients Receiving Argatroban Therapy.
To determine change of QTc interval during intravenous argatroban infusion in patients undergoing percutaneous coronary intervention (PCI)
Read the detailed description
Primary objective:
To determine change of corrected QT interval (QTc) during intravenous argatroban infusion in patients undergoing percutaneous coronary intervention (PCI).
Secondary objectives:
- Determination of the QTc interval after sufficient wash-out period by ECG-3 which needed to be performed > 8 but ≤ 28 hours after termination of prolonged argatroban infusion.
- Investigation of dependence of QTc interval on gender and applied doses.
- Determination of coagulation status during argatroban therapy.
- Assessment of safety-related events within the scope of anticoagulation with argatroban, for example bleeding events or thromboembolic events.
- Being tested
- Argatroban
- Medical subject headings
- Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArgatrobanDrug
Also called Arganova, Argatra, Novastan
Patients received an intravenous (i.v.) bolus of 300 μg/kg argatroban administered over a span of 3 to 5 minutes followed by the i.v. infusion of argatroban at 20 μg/kg/min until the end of the procedure. ACT was checked 5 minutes after bolus dose.
If ACT remained below the target of 300 s, the patient received an additional i.v. bolus injection of 150 μg/kg and the infusion dose was raised up to 30 μg/kg/min.
In cases ACT > 450 s, the infusion was reduced to 15 μg/kg/min and the value was checked again after 5 minutes.
As soon as the target ACT (between 300 s and 450 s) was reached, infusion dose remained unchanged during the PCI procedure.
Depending on clinical relevancy further ACT assessments were possible.
| Study group | Role | What they receive |
|---|---|---|
| Argatroban | Other | Not described Receives: Drug: Argatroban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Difference in QTc Interval Between ECG-2 and ECG-1 (ITT Population)
It was investigated if a mean QTc prolongation of more than 10 ms occurred between ECG-2 and ECG-1
Measured: ECG-2 was recorded immediately after cardiac intervention when patient was fully anticoagulated with argatroban and ECG-1 was recorded at baseline prior to first bolus dose of argatroban (argatroban-free status).
Mean Difference in QTc Interval Between ECG-2 and ECG-1 (ITT Population/Subgroup Male or Female)
It was investigated if a mean QTc prolongation of more than 10 ms occurred between ECG-2 and ECG-1
Measured: ECG-2 was recorded immediately after cardiac intervention when patient was fully anticoagulated with argatroban and ECG-1 was recorded at baseline prior to first bolus dose of argatroban (argatroban-free status).
Mean Difference in QTc Interval Between ECG-2 and ECG-1 (ITT Population/Centre 01 or Centre 02)
It was investigated if a mean QTc prolongation of more than 10 ms occurred between ECG-2 and ECG-1
Measured: ECG-2 was recorded immediately after cardiac intervention when patient was fully anticoagulated with argatroban and ECG-1 was recorded at baseline prior to first bolus dose of argatroban (argatroban-free status).
Secondary outcomes (1)
Proportion of Patients With a Prolongation of QTc Interval to >500 ms at ECG-2
Number of patients of ITT population exhibiting QTc interval of > 500 ms
Measured: ECG-2 immediately after argatroban infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start18 Apr 2017
- Primary completion6 May 2021
- Study completion6 May 2021
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.
- Other trials for Stable Coronary Artery Disease (CAD)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Deputy General Manager Scientific Medical Affairs, Study director, Tanabe Pharma GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740371
- Sponsor's protocol ID
- ARG-E08
- Other IDs
- 2016-003521-42, 2016
- Acronym
- SAICoDis
- Status last verified
- Dec 2025
- First submitted
- 13 Feb 2023
- Last updated
- 30 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAICoDis - Safety of Argatroban Infusion in Conduction Disturbances. A Prospective, Open, Multicenter Safety Study to Investigate Conduction Disturbances in Patients Receiving Argatroban Therapy.
- ClinicalTrials.gov ID
- NCT05740371
- Acronym / sponsor ID
- SAICoDis / ARG-E08
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tanabe Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2017 (actual)
- Primary completion
- 6 May 2021 (actual)
- Study completion
- 6 May 2021 (actual)
- First posted
- 23 Feb 2023 (actual)
- Results
- Posted 18 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine change of QTc interval during intravenous argatroban infusion in patients undergoing percutaneous coronary intervention (PCI)
Detailed description
Primary objective:
To determine change of corrected QT interval (QTc) during intravenous argatroban infusion in patients undergoing percutaneous coronary intervention (PCI).
Secondary objectives:
- Determination of the QTc interval after sufficient wash-out period by ECG-3 which needed to be performed > 8 but ≤ 28 hours after termination of prolonged argatroban infusion.
- Investigation of dependence of QTc interval on gender and applied doses.
- Determination of coagulation status during argatroban therapy.
- Assessment of safety-related events within the scope of anticoagulation with argatroban, for example bleeding events or thromboembolic events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Argatroban | Other | Drug: Argatroban |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of stable CAD or unstable angina (troponin negative, i.e. within the normal range for the study site) with low to moderate anatomic risk.
- Patient required 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.
- Patient was on adequate platelet inhibition therapy after having received a loading dose with ASA and clopidogrel before start of intervention (this additional inclusion criterion was introduced with study protocol version 1.6, dated 14.12.2018)
- Willingness to give written informed consent, written consent for data protection (legal requirement in Germany "datenschutzrechtliche Einwilligung") and willingness to participate and to comply with the requirements of the study protocol.
- The patient (female/male) was at least 18 years of age.
Key exclusion criteria (30 listed)
- Patient was indicated for highly complex 3-vessel intervention.
- The female patient was pregnant (exclusion by routine urine test) or was nursing during therapy period.
- Patients who were currently participating in another clinical trial or patients who participated in another clinical trial during the last 3 months prior to study start (date of treatment visit).
- History of drug, alcohol or chemical abuse within 6 months prior to study start.
- Planned surgical intervention other than study procedure within 7 days after study start.
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 |
|---|---|---|
| ArgatrobanAlso: Arganova, Argatra, NovastanPatients received an intravenous (i.v.) bolus of 300 μg/kg argatroban administered over a span of 3 to 5 minutes followed by the i.v. infusion of argatroban at 20 μg/kg/min until the end of the procedure. ACT was checked 5 minutes after bolus dose. If ACT remained below the target of 300 s, the patient received an additional i.v. bolus injection of 150 μg/kg and the infusion dose was raised up to 30 μg/kg/min. In cases ACT > 450 s, the infusion was reduced to 15 μg/kg/min and the value was checked again after 5 minutes. As soon as the target ACT (between 300 s and 450 s) was reached, infusion dose remained unchanged during the PCI procedure. Depending on clinical relevancy further ACT assessments were possible. | Drug | Argatroban |
Primary outcome
Mean Difference in QTc Interval Between ECG-2 and ECG-1 (ITT Population)
Time frame: ECG-2 was recorded immediately after cardiac intervention when patient was fully anticoagulated with argatroban and ECG-1 was recorded at baseline prior to first bolus dose of argatroban (argatroban-free status).
It was investigated if a mean QTc prolongation of more than 10 ms occurred between ECG-2 and ECG-1
Mean Difference in QTc Interval Between ECG-2 and ECG-1 (ITT Population/Subgroup Male or Female)
Time frame: ECG-2 was recorded immediately after cardiac intervention when patient was fully anticoagulated with argatroban and ECG-1 was recorded at baseline prior to first bolus dose of argatroban (argatroban-free status).
It was investigated if a mean QTc prolongation of more than 10 ms occurred between ECG-2 and ECG-1
Mean Difference in QTc Interval Between ECG-2 and ECG-1 (ITT Population/Centre 01 or Centre 02)
Time frame: ECG-2 was recorded immediately after cardiac intervention when patient was fully anticoagulated with argatroban and ECG-1 was recorded at baseline prior to first bolus dose of argatroban (argatroban-free status).
It was investigated if a mean QTc prolongation of more than 10 ms occurred between ECG-2 and ECG-1
1 secondary outcome
Proportion of Patients With a Prolongation of QTc Interval to >500 ms at ECG-2
Time frame: ECG-2 immediately after argatroban infusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Deputy General Manager Scientific Medical Affairs study director
Tanabe Pharma GmbH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Argatroban in people with Stable Coronary Artery Disease (CAD) and Unstable Angina (Troponin Negative), run by Tanabe Pharma GmbH at 2 sites in Germany.
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 6 inclusion and 30 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 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 18 Mar 2024). 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?
Mean Difference in QTc Interval Between ECG-2 and ECG-1 (ITT Population) (time frame: ECG-2 was recorded immediately after cardiac intervention when patient was fully anticoagulated with argatroban and ECG-1 was recorded at baseline prior to first bolus dose of argatroban (argatroban-free status).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.