Safety of Argatroban Infusion in Conduction Disturbances

NCT05740371 | Completed Phase 4 Results

• 2 other identifiers: ARG-E082016-003521-42
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

To determine change of QTc interval during intravenous argatroban infusion in patients undergoing percutaneous coronary intervention (PCI)

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  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

  ECG-2 immediately after argatroban infusion

Study Arms (1)

Argatroban

OTHER

Drug: Argatroban

Interventions

Argatroban DRUG

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.

Also known as: Arganova, Argatra, Novastan

Argatroban

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Patient was indicated for highly complex 3-vessel intervention.
• 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:

Sponsors & Collaborators

• Tanabe Pharma GmbH: lead

Study Sites (2)

University Hospital Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

Herz-Kreislauf-Zentrum Klinikum Hersfeld-Rotenburg

Rotenburg an der Fulda, Hesse, 36199, Germany

Location

MeSH Terms

Conditions

Angina, Unstable

Interventions

argatroban

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

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

regulatorycontact.DE@mb.tanabe-pharma.com

Please email

Study Officials

• Deputy General Manager Scientific Medical Affairs

  Tanabe Pharma GmbH

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: February 23, 2023
• Study Start: April 18, 2017
• Primary Completion: May 6, 2021
• Study Completion: May 6, 2021
• Last Updated: December 30, 2025
• Results First Posted: March 18, 2024

Record last verified: 2025-12

Locations

DE (2)