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Safety of Argatroban Infusion in Conduction Disturbances (SAICoDis)

Primary Purpose

Stable Coronary Artery Disease (CAD), Unstable Angina (Troponin Negative)

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Argatroban
Sponsored by
Mitsubishi Tanabe Pharma GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stable Coronary Artery Disease (CAD)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Sites / Locations

  • University Hospital Frankfurt
  • Herz-Kreislauf-Zentrum Klinikum Hersfeld-Rotenburg

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Argatroban

Arm Description

Outcomes

Primary Outcome Measures

Mean difference in QTc interval between ECG-2 and ECG-1
It was investigated if a mean QTc prolongation of more than 10 ms occurred between ECG-2 and ECG-1

Secondary Outcome Measures

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

Full Information

First Posted
February 13, 2023
Last Updated
February 24, 2023
Sponsor
Mitsubishi Tanabe Pharma GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT05740371
Brief Title
Safety of Argatroban Infusion in Conduction Disturbances
Acronym
SAICoDis
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 18, 2017 (Actual)
Primary Completion Date
May 6, 2021 (Actual)
Study Completion Date
May 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Coronary Artery Disease (CAD), Unstable Angina (Troponin Negative)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Argatroban
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Argatroban
Other Intervention Name(s)
Arganova, Argatra, Novastan
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean difference in QTc interval between ECG-2 and ECG-1
Description
It was investigated if a mean QTc prolongation of more than 10 ms occurred between ECG-2 and ECG-1
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).
Secondary Outcome Measure Information:
Title
Proportion of patients with a prolongation of QTc interval to >500 ms at ECG-2
Description
Number of patients of ITT population exhibiting QTc interval of > 500 ms
Time Frame
ECG-2 immediately after argatroban infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deputy General Manager Scientific Medical Affairs
Organizational Affiliation
Mitsubishi Tanabe Pharma GmbH
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Frankfurt
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Herz-Kreislauf-Zentrum Klinikum Hersfeld-Rotenburg
City
Rotenburg an der Fulda
State/Province
Hessen
ZIP/Postal Code
36199
Country
Germany

12. IPD Sharing Statement

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Safety of Argatroban Infusion in Conduction Disturbances

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