Myocardial Ischaemic SyndromePANDANCT06730802
Protective Effect of PCSK9 Inhibitor Against Negative Inflammatory Response and Organ Dysfunction After Coronary Artery Bypass Grafting (PANDA VIII)
A study testing PCSK9 inhibitor and Statin in people with Myocardial Ischaemic Syndrome and Coronary Heart Disease, run by Nanjing Medical University at 2 sites in China.
Trial summary
This is a multi-center, randomized controlled study to investigate whether early offering PCSK9 inhibitor can protect against negative inflammatory response and organ dysfunction after coronary artery bypass grafting (CABG). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Ischaemic Syndrome, Coronary Heart Disease
- What is being tested?
- PCSK9 inhibitor and Statin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2025to 31 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18 years of age
- Patients with myocardial ischemic syndromes (with any of the following):
- Patients are ready to undergo coronary artery bypass grafting (CABG) with 1 month;
- Participate voluntarily and sign an informed consent
Who cannot join
- Pregnant and lactating women ii. During the study period and within 3 months of receiving the last dose of the study drug, women with fertility intentions and men unwilling to use effective contraceptive methods iii. Have used PCSK9 inhibitors within 3 months before enrollment, or have a history of severe allergic reactions to PCSK9 inhibitors iv. Severe infections requiring intravenous antibiotics v. HIV-positive or history of acquired immunodeficiency syndrome (AIDS) vi. With cognitive impairment or psychiatric illnesses
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality
Hai-yang Li, MD, ocean0203@163.com
Hai-yang Li
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Lu-yao Ma, MD, 18801281613, maluyao@jsph.org.cn
Lu-yao Ma, MD, 02568303101, maluyao@jsph.org.cn
About this study
This is a multi-center, randomized controlled study to investigate whether early offering PCSK9 inhibitor can protect against negative inflammatory response and organ dysfunction after coronary artery bypass grafting (CABG). Subjects with myocardial ischaemic syndromes (MIS) will be enrolled in this study after consent information. After randomization, the control group will receive standard therapy, while the experiment group will receive first PCSK9 inhibitor before CABG, then twice a month until 3 months later. Six month after CABG, CRP will be used to evaluate inflammation, and echocardiography and coronary CTA will be used to evaluate cardiovascular function.
- Being tested
- PCSK9 inhibitor, Statin
- Keywords
- inflammation, CABG
- Medical subject headings
- Coronary Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCSK9 inhibitorDrug
the experiment group will receive first PCSK9 inhibitor before CABG, then twice a month until 3 months later.
StatinDrug
the control group will receive standard statin therapy.
| Study group | Role | What they receive |
|---|---|---|
| PCSK9 inhibitor | Experimental | the experiment group will receive first PCSK9 inhibitor before CABG, then twice a month until 3 months later Receives: Drug: PCSK9 inhibitor |
| Statin | Sham comparator | the control group will receive standard statin therapy. Receives: Drug: Statin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular and Cerebrovascular Events
Major Adverse Cardiovascular and Cerebrovascular Events include cardiac death, reinfarction, emergency coronary revascularization and stroke
Measured: 6 months after surgery
Secondary outcomes (1)
C-reactive protein
Peripheral blood C-reactive protein
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myocardial Ischaemic SyndromeStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Liu, Nanjing Medical University
- Investigators
- Lu-yao Ma, MD, Study director, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06730802
- Sponsor's protocol ID
- PANDA VIII
- Acronym
- PANDA
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Oyama K, Furtado RHM, Fagundes A Jr, Zelniker TA, Tang M, Kuder J, Murphy SA, Hamer A, Wang H, Keech AC, Giugliano RP, Sabatine MS, Bergmark BA. Effect of Evolocumab on Complex Coronary Disease Requiring Revascularization. J Am Coll Cardiol. 2021 Jan 26;77(3):259-267. doi: 10.1016/j.jacc.2020.11.011. Epub 2020 Nov 13.
PubMed 33197560Na HR, Kwon OS, Kang JK, Kim YH, Lim JY. Evolocumab administration prior to Coronary Artery Bypass Grafting in patients with multivessel coronary artery disease (EVOCABG): study protocol for a randomized controlled clinical trial. Trials. 2022 May 23;23(1):430. doi: 10.1186/s13063-022-06398-3.
PubMed 35606883Nasso G, Larosa C, Bartolomucci F, Brigiani MS, Contegiacomo G, Demola MA, Vignaroli W, Tripoli A, Girasoli C, Lisco R, Trivigno M, Tunzi RM, Loizzo T, Hila D, Franchino R, Amodeo V, Ventra S, Diaferia G, Schinco G, Agro FE, Zingaro M, Rosa I, Lorusso R, Del Prete A, Santarpino G, Speziale G. Safety and Efficacy of PCSK9 Inhibitors in Patients with Acute Coronary Syndrome Who Underwent Coronary Artery Bypass Grafts: A Comparative Retrospective Analysis. J Clin Med. 2024 Feb 4;13(3):907. doi: 10.3390/jcm13030907.
PubMed 38337601
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Effect of PCSK9 Inhibitor Against Negative Inflammatory Response and Organ Dysfunction After Coronary Artery Bypass Grafting (PANDA VIII)
- ClinicalTrials.gov ID
- NCT06730802
- Acronym / sponsor ID
- PANDA / PANDA VIII
- Keywords
- inflammation, CABG
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University, Beijing Anzhen Hospital
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Dec 2024 (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.
This is a multi-center, randomized controlled study to investigate whether early offering PCSK9 inhibitor can protect against negative inflammatory response and organ dysfunction after coronary artery bypass grafting (CABG). Subjects with myocardial ischaemic syndromes (MIS) will be enrolled in this study after consent information. After randomization, the control group will receive standard therapy, while the experiment group will receive first PCSK9 inhibitor before CABG, then twice a month until 3 months later. Six month after CABG, CRP will be used to evaluate inflammation, and echocardiography and coronary CTA will be used to evaluate cardiovascular function.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCSK9 inhibitor | Experimental | Drug: PCSK9 inhibitorthe experiment group will receive first PCSK9 inhibitor before CABG, then twice a month until 3 months later |
| Statin | Sham comparator | Drug: Statinthe control group will receive standard statin therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female ≥ 18 years of age
- Patients with myocardial ischemic syndromes (with any of the following):
- Patients are ready to undergo coronary artery bypass grafting (CABG) with 1 month;
- Participate voluntarily and sign an informed consent
Key exclusion criteria (1 listed)
- Pregnant and lactating women ii. During the study period and within 3 months of receiving the last dose of the study drug, women with fertility intentions and men unwilling to use effective contraceptive methods iii. Have used PCSK9 inhibitors within 3 months before enrollment, or have a history of severe allergic reactions to PCSK9 inhibitors iv. Severe infections requiring intravenous antibiotics v. HIV-positive or history of acquired immunodeficiency syndrome (AIDS) vi. With cognitive impairment or psychiatric illnesses
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 |
|---|---|---|
| PCSK9 inhibitorthe experiment group will receive first PCSK9 inhibitor before CABG, then twice a month until 3 months later. | Drug | PCSK9 inhibitor |
| Statinthe control group will receive standard statin therapy. | Drug | Statin |
Primary outcome
Major Adverse Cardiovascular and Cerebrovascular Events
Time frame: 6 months after surgery
Major Adverse Cardiovascular and Cerebrovascular Events include cardiac death, reinfarction, emergency coronary revascularization and stroke
1 secondary outcome
C-reactive protein
Time frame: 6 months after surgery
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 12 Dec 2024.
- Results publication: PubMed 33197560Oyama K, Furtado RHM, Fagundes A Jr, Zelniker TA, Tang M, Kuder J, Murphy SA, Hamer A, Wang H, Keech AC, Giugliano RP, Sabatine MS, Bergmark BA. Effect of Evolocumab on Complex Coronary Disease Requiring Revascularization. J Am Coll Cardiol. 2021 Jan 26;77(3):259-267. doi: 10.1016/j.jacc.2020.11.011. Epub 2020 Nov 13.
- Results publication: PubMed 35606883Na HR, Kwon OS, Kang JK, Kim YH, Lim JY. Evolocumab administration prior to Coronary Artery Bypass Grafting in patients with multivessel coronary artery disease (EVOCABG): study protocol for a randomized controlled clinical trial. Trials. 2022 May 23;23(1):430. doi: 10.1186/s13063-022-06398-3.
- Results publication: PubMed 38337601Nasso G, Larosa C, Bartolomucci F, Brigiani MS, Contegiacomo G, Demola MA, Vignaroli W, Tripoli A, Girasoli C, Lisco R, Trivigno M, Tunzi RM, Loizzo T, Hila D, Franchino R, Amodeo V, Ventra S, Diaferia G, Schinco G, Agro FE, Zingaro M, Rosa I, Lorusso R, Del Prete A, Santarpino G, Speziale G. Safety and Efficacy of PCSK9 Inhibitors in Patients with Acute Coronary Syndrome Who Underwent Coronary Artery Bypass Grafts: A Comparative Retrospective Analysis. J Clin Med. 2024 Feb 4;13(3):907. doi: 10.3390/jcm13030907.
- 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.
Lu-yao Ma, MD study director
The First Affiliated Hospital with Nanjing Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCSK9 inhibitor and Statin in people with Myocardial Ischaemic Syndrome and Coronary Heart Disease, run by Nanjing Medical University at 2 sites in China.
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 4 inclusion and 1 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: opening soon, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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. Some participants in this study may receive a placebo. 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 Hong Liu, MD (18801281613, dr.hongliu@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular and Cerebrovascular Events (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06730802, which also lists 3 linked publications.
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 12 Dec 2024.