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New treatment option for CAD - Coronary Artery Disease
Official title Comparative Analysis of Analgesic Approaches in the Early Period After CABG
ClinicalTrials.gov ID: NCT07451522
What this study is testing
What is Tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amide)?
Tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amide) is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for cad - coronary artery disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to study postoperative analgesia in patients undergoing CABG. And learn if tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amid) treats pain not inferiory then morphine.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- ASA score less then 3, Signed inform consent, Absence of preoperative drugs administration that affects patient's perception of pain, No active...
You likely can't join if
- (the presence of at least one is sufficient):
- Failure to meet the inclusion criteria.
- High severity according to ASA (class IV or higher), which is associated with a high probability of prolonged mechanical ventilation, hemodynamic...
- Contraindications to the use of tafalgin and/or morphine in accordance with the approved Summary of Product Characteristics (hypersensitivity to...
- Pregnancy or lactation.
- Acute or prolonged chronic intoxication with drugs or substances depressing the central nervous system (alcohol, barbiturates, opioid drugs...
See the full eligibility criteria
- ASA score less then 3, Signed inform consent, Absence of preoperative drugs administration that affects patient's perception of pain, No active infection process, BMI index \>18,5 kg\\m2 and \< 35 kg/m2, CABG, Age 18-75...
- (the presence of at least one is sufficient):
- Failure to meet the inclusion criteria.
- High severity according to ASA (class IV or higher), which is associated with a high probability of prolonged mechanical ventilation, hemodynamic instability, and inability to use drugs affecting cardiac output and/or...
- Contraindications to the use of tafalgin and/or morphine in accordance with the approved Summary of Product Characteristics (hypersensitivity to tafalgin, morphine, other opioids, or any excipients).
- Pregnancy or lactation.
- Acute or prolonged chronic intoxication with drugs or substances depressing the central nervous system (alcohol, barbiturates, opioid drugs, benzodiazepines).
- Use of monoamine oxidase inhibitors (MAOIs) or less than 14 days since their discontinuation.
- Liver cirrhosis, Child-Pugh class C.
- Acute renal failure requiring renal replacement therapy.
- Unresected malignant neoplasm.
- Mesenteric thrombosis or another severe abdominal pain syndrome of unclear etiology at the time of inclusion.
- Simultaneous participation in another clinical study.
- Marked CNS depression due to any cause, except for acute poisoning.
- COPD stage III and/or bronchial asthma in the exacerbation phase.
- Any clinically significant condition, disease, or circumstance in the medical history that, in the opinion of the investigator, precludes participation in the study.
- Psychiatric, physical, or other conditions preventing adequate assessment of the patient's behavior or proper compliance with the study protocol.
- Postoperative hemodynamic instability requiring high-dose inotropic and/or vasopressor support (epinephrine \> 0.1 μg/kg/min, dopamine \> 10 μg/kg/min, norepinephrine \> 0.2 μg/kg/min) and/or mechanical circulatory...
- Refusal to participate in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Vladivostok, Outside US, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vladivostok, Outside US, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.