CAD - Coronary Artery DiseaseCABG-PAINNCT07451522
Comparative Analysis of Analgesic Approaches in the Early Period After CABG
A study testing Tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amide) and Morphine (+) in people with CAD - Coronary Artery Disease and CABG, run by Primorsky Regional General Hospital #1 at 1 site in Russia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- CAD - Coronary Artery Disease, CABG, Analgesia Assessment
- What is being tested?
- Tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amide) and Morphine (+)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 1 Dec 2025to 15 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 years
- Exclusion Criteria (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 total peripheral vascular resistance.
- 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.
Show all 19Show fewer
- 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 support.
- Refusal to participate in the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Primorsky Regional General Hospital #1
Vladivostok, Outside US, 690091
Vladislav Rublev, 89644530700, dr.rublev.v@gmail.com
About this study
Official title: Comparative Characteristics of Analgesia Methods in the Early Postoperative Period After Coronary Artery Bypass Grafting (CABG)
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. The main questions it aims to answer are:
Does tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amid) lower the VAS score same way as a morphine? What medical problems do participants have when taking tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amid)?
Read more
Participants will:
Group (1)- subcutaneous single dose of morphine 10 mg would be administred based on VAS score > 3 during 24 hours after CABG.
Exprimental group (2)- subcutaneous single dose of tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amid) - 0.4 mg would be administred based on VAS score > 3 during 24 hours after CABG.
Efficacy was assessed using the VAS scale decreassion. Hemodynamic parameters and arterial blood gases were also assessed.
- Conditions
- CAD - Coronary Artery Disease, CABG, Analgesia Assessment
- Being tested
- Tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amide), Morphine (+)
- Keywords
- CABG, CAD, Morphine, Tafalgin, VAS
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amide)Drug
Postoperative analgesia after CABG with tafalgin
Morphine (+)Drug
Postoperative analgesia wtih morphine
| Study group | Role | What they receive |
|---|---|---|
| Morphine | Active comparator | Patients after CABG with morphine postoperative analgesia Receives: Drug: Morphine (+) |
| Tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amide) | Experimental | Patients after CABG with tafalgin postoperative analgesia Receives: Drug: Tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression or compare pain severity between patients
Measured: 24 hours after CABG
Secondary outcomes (5)
Arterial Blood Gases (ABGs) pH
Arterial blood gases are a diagnostic test measuring pH levels in arterial blood to evaluate lung function and acid-base balance.
Measured: 24 hours after CABG
Arterial Blood Gases (ABGs) oxygen (PaO2) levels
Arterial blood gases are a diagnostic test measuring oxygen (PaO2) levels in arterial blood to evaluate lung function and acid-base balance.
Measured: 24 hours after CABG
Arterial Blood Gases (ABGs) carbon dioxide (PaCO2) levels
Arterial blood gases are a diagnostic test measuring carbon dioxide (PaCO2) levels in arterial blood to evaluate lung function and acid-base balance.
Measured: 24 hours after CABG
Haemodynamics evaluation (Intra-arterial blood pressure (IABP))
Intra-arterial blood pressure (IABP) monitoring provides continuous, real-time arterial pressure measurement, serving as the gold standard for managing hypertension in critical care.
Measured: 24 hours after CABG
Haemodynamics evaluation (Heart rate (HR))
This assessment evaluates cardiac function, identifies rhythm irregularities
Measured: 24 hours after CABG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Dec 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CAD - Coronary Artery DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Primorsky Regional General Hospital #1
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Vladislav Rublev, Primorsky Regional General Hospital #1
- Investigators
- Evgenii Kokarev, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07451522
- Sponsor's protocol ID
- LEC028
- Acronym
- CABG-PAIN
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Characteristics of Analgesia Methods in the Early Postoperative Period After Coronary Artery Bypass Grafting (CABG)
- ClinicalTrials.gov ID
- NCT07451522
- Acronym / sponsor ID
- CABG-PAIN / LEC028
- Conditions
- CAD - Coronary Artery Disease, CABG, Analgesia Assessment
- Keywords
- CABG, CAD, Morphine, Tafalgin, VAS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Primorsky Regional General Hospital #1Other government
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. The main questions it aims to answer are:
Does tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amid) lower the VAS score same way as a morphine? What medical problems do participants have when taking tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amid)?
Participants will:
Group (1)- subcutaneous single dose of morphine 10 mg would be administred based on VAS score > 3 during 24 hours after CABG.
Exprimental group (2)- subcutaneous single dose of tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amid) - 0.4 mg would be administred based on VAS score > 3 during 24 hours after CABG.
Efficacy was assessed using the VAS scale decreassion. Hemodynamic parameters and arterial blood gases were also assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morphine | Active comparator | Drug: Morphine (+)Patients after CABG with morphine postoperative analgesia |
| Tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amide) | Experimental | Drug: Tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amide)Patients after CABG with tafalgin postoperative analgesia |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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 years
- 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 total peripheral vascular resistance.
- 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.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amide)Postoperative analgesia after CABG with tafalgin | Drug | Tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amide) |
| Morphine (+)Postoperative analgesia wtih morphine | Drug | Morphine |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: 24 hours after CABG
The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression or compare pain severity between patients
5 secondary outcomes
Arterial Blood Gases (ABGs) pH
Time frame: 24 hours after CABG
Arterial Blood Gases (ABGs) oxygen (PaO2) levels
Time frame: 24 hours after CABG
Arterial Blood Gases (ABGs) carbon dioxide (PaCO2) levels
Time frame: 24 hours after CABG
Haemodynamics evaluation (Intra-arterial blood pressure (IABP))
Time frame: 24 hours after CABG
Haemodynamics evaluation (Heart rate (HR))
Time frame: 24 hours after CABG
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Evgenii Kokarev, PhD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amide) and Morphine (+) in people with CAD - Coronary Artery Disease and CABG, run by Primorsky Regional General Hospital #1 at 1 site in Russia.
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 19 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vladislav Rublev, PhD (+79644530700, dr.rublev.v@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: 24 hours after CABG). 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 5 Mar 2026.