Impact of the analgesic drug dipyrone (metamizole) on the antiplatelet effect of aspirin in patients after cardiac surgyer

Antiplatelet effect of acetylsalicylic acid in patients after cardiac surgery: Impact of dipyrone (metamizole) - Aspirin-Metamizole Drug-Drug Interaction

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000017-20-DE

Enrollment

150

Registered

2018-05-16

Start date

2018-07-17

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antithrombotic therapy after surgical replacement of stenotic heart valve by a bioprosthesis or mitral valve repair

Interventions

Trade Name: Novaminsulfon-ratiopharm® 1 g/2 ml Injektionslösung Product Name: Novaminsulfon-ratiopharm® 1 g/2 ml Pharmaceutical Form: Injection INN or P

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Clinical indication for surgical replacement of the stenotic aortic valve by a bioprosthesis without concomitant CABG or surgical mitral valve repair - Age > 50years - Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 135

Exclusion criteria

Exclusion criteria: - Re-do heart surgery - Indication for oral anticoagulation - Known disorders of coagulation - Chronic hepatic disease - Chronic alcohol abuse - Known malnutrition status - Creatine clearance <30 ml7Min (CKD-EPI-formula) - End-stage renal disease requring hemodialysis - Known hematological disorders - Peri-or postoperative transfusion of platelets - Treatment with aspirin within 10 days prior to surgery - Positive result in pregnancy in urine testing in female pre-menopausal patients - Participation in any interventional study according to German Drug Law (AMG) or Medicinal Device Law (MPG) within 30 days before enrollment in this study - Known hypersensitivity to dipyrone (metamizole) or paracetamol

Design outcomes

Primary

Measure	Time frame
Main Objective: Comparative assessment of the impact of concomitant treatment with the analgesic drugs dipyrone (metamizole) versus paracetamol on the antiplatelet effect of low-dose aspirin in the early postoperative period after surgical replacement of the stenotic aortic valve by a bioprosthesis or surgical mitral valve repair; Secondary Objective: - Proportion of patients with an adequate antiplatelet response to low dose aspirin by thromboxane B2 assay at day 2 after surgical replacement of the stenotic aortic valve by a bioprosthesis or surgical mitral valve repair - Assessment of platelet reactivity by use of other laboratory assays respective different stimulants. - Immature platelet fraction and immature platelet count - hsCRP and IL-6 in plasma/serum ;Primary end point(s): Proportion of patients with an adequate antiplatelet response to low dose aspirin (100 mg/day) at day 4/5 after surgical replacement of the stenotic aortic valve by a bioprosthesis or surgical mitral valve repair. Adequate response to aspirin is assessed by determination of thromboxane B2 after stimulation of platelet rich plasma with arachidonic acid;Timepoint(s) of evaluation of this end point: Day 4/5 after surgical replacement of the aortic valve or surgical mitral valve repair	—

Measure

Time frame

Main Objective: Comparative assessment of the impact of concomitant treatment with the analgesic drugs dipyrone (metamizole) versus paracetamol on the antiplatelet effect of low-dose aspirin in the early postoperative period after surgical replacement of the stenotic aortic valve by a bioprosthesis or surgical mitral valve repair; Secondary Objective: - Proportion of patients with an adequate antiplatelet response to low dose aspirin by thromboxane B2 assay at day 2 after surgical replacement of the stenotic aortic valve by a bioprosthesis or surgical mitral valve repair - Assessment of platelet reactivity by use of other laboratory assays respective different stimulants. - Immature platelet fraction and immature platelet count - hsCRP and IL-6 in plasma/serum ;Primary end point(s): Proportion of patients with an adequate antiplatelet response to low dose aspirin (100 mg/day) at day 4/5 after surgical replacement of the stenotic aortic valve by a bioprosthesis or surgical mitral valve repair. Adequate response to aspirin is assessed by determination of thromboxane B2 after stimulation of platelet rich plasma with arachidonic acid;Timepoint(s) of evaluation of this end point: Day 4/5 after surgical replacement of the aortic valve or surgical mitral valve repair

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Secondary

Measure	Time frame
Secondary end point(s): - Proportion of patients with an adequate antiplatelet response to low dose aspirin by thromboxane B2 assay at day 2 after surgical replacement of the stenotic aortic valve by a bioprosthesis or mitral valve repair. Adequate response to aspirin is assessed by determination of thromboxane B2 after stimulation of platelet rich plasma with arachidonic acid Assessment of platelet reactivity by other laboratory assays respective different stimulants. - Platelet reactivity by light transmission aggregometry after stimulation of platelet rich plasma with arachidonic acid 200 mg/L - Platelet reactivity by Multiple Electrode Impedance Aggregometry after stimulation of hirudine anticoagulated blood with arachidonic acid (ASPItest) - Platelet reactivity by light transmission aggregometry after stimulation of platelet rich plasma with thrombin receptor activating peptide (TRAP) - Platelet reactivity by Multiple Electrode Impedance Aggregometry after stimulation of hirudine anticoagulated blood with thrombin receptor activating peptide (TRAPtest) - Platelet reactivity by light transmission aggregometry after ex vivo incubation with different concentrations of aspirin and stimulation with arachidonic acid (500 mg/L) - Immature platelet fraction and immature platelet count - hsCRP and IL-6 in plasma/serum ;Timepoint(s) of evaluation of this end point: Days 1, 2 respective 4/5 after surgical replacement of the aortic valve or surgical mitral valve repair	—

Measure

Time frame

Secondary end point(s): - Proportion of patients with an adequate antiplatelet response to low dose aspirin by thromboxane B2 assay at day 2 after surgical replacement of the stenotic aortic valve by a bioprosthesis or mitral valve repair. Adequate response to aspirin is assessed by determination of thromboxane B2 after stimulation of platelet rich plasma with arachidonic acid Assessment of platelet reactivity by other laboratory assays respective different stimulants. - Platelet reactivity by light transmission aggregometry after stimulation of platelet rich plasma with arachidonic acid 200 mg/L - Platelet reactivity by Multiple Electrode Impedance Aggregometry after stimulation of hirudine anticoagulated blood with arachidonic acid (ASPItest) - Platelet reactivity by light transmission aggregometry after stimulation of platelet rich plasma with thrombin receptor activating peptide (TRAP) - Platelet reactivity by Multiple Electrode Impedance Aggregometry after stimulation of hirudine anticoagulated blood with thrombin receptor activating peptide (TRAPtest) - Platelet reactivity by light transmission aggregometry after ex vivo incubation with different concentrations of aspirin and stimulation with arachidonic acid (500 mg/L) - Immature platelet fraction and immature platelet count - hsCRP and IL-6 in plasma/serum ;Timepoint(s) of evaluation of this end point: Days 1, 2 respective 4/5 after surgical replacement of the aortic valve or surgical mitral valve repair

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Countries

Germany

Contacts

Public ContactAbt. Klinische Pharmakologie

Universitäts-Herzzentrum Freiburg • Bad Krozingen

KlinPharma@universitaets-herzzentrum.de4976334022481

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026