Coronary Artery DiseasePhase 4NCT06520904
Effect of PCSK9 Inhibitors on Coronary Atherosclerotic Plaques Derived From Optical Coherence Tomography
A Phase 4 study testing PCSK9 inhibitor and Statin in people with Coronary Artery Disease and Optical Coherence Tomography, run by First Affiliated Hospital of Xinjiang Medical University at 1 site in China.
Trial summary
The presence of coronary atherosclerotic vulnerable plaque significantly impacts the clinical outcomes of patients diagnosed with coronary artery disease (CAD). However, the influence of PCSK9 inhibitors on stabilizing coronary atherosclerotic plaques in individuals with early-onset CAD, evaluated through optical… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Coronary Artery Disease, Optical Coherence Tomography
- What is being tested?
- PCSK9 inhibitor and Statin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 396 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 31 Dec 2026
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men aged 18-55 years and women aged 18-65 years;
- CAD patients with coronary angiographically confirmed lesions in ≥2 vessels; at least one vessel was critically diseased (50-70% stenosis level);
- LDL-C >3.4 mmol/L without regular statin therapy or LDL-C >1.8 mmol/L after 4 weeks of statin lipid-lowering therapy.
Who cannot join
- Known allergies or contraindications to PCSK9 inhibitors and/or statin therapy;
- Prior use of PCSK9 inhibitors;
- Prior history of hemorrhagic stroke;
- Prior coronary artery bypass grafting or coronary intervention;
- Inability to perform OCT imaging or unclear imaging;
- Severe renal insufficiency (creatinine clearance < 30 mL/min);
Show all 11Show fewer
- Severe hepatic dysfunction;
- Baseline triglycerides > 5.6 mmol/L;
- Pregnant or lactating women;
- Life expectancy not exceeding 1 year;
- In the judgment of the investigator, unsuitable for this study for any reason.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830011
Sen Liu, MD, 09914366872 ext. +86, 463387160@qq.com
About this study
Official title: Effect of PCSK9 Inhibitors on Coronary Atherosclerotic Plaques Derived From Optical Coherence Tomography in Patients With Premature Coronary Artery Disease: a Randomized Controlled Trial
The presence of coronary atherosclerotic vulnerable plaque significantly impacts the clinical outcomes of patients diagnosed with coronary artery disease (CAD). However, the influence of PCSK9 inhibitors on stabilizing coronary atherosclerotic plaques in individuals with early-onset CAD, evaluated through optical coherence tomography (OCT), remains inadequately understood. Moreover, there is a notable absence of relevant randomized controlled trials investigating this phenomenon. This current study represents a single-center, randomized, controlled, open-label trial conducted among Asian patients with early-onset CAD. Its principal objective was to explore the effects of PCSK9 inhibitors on coronary atherosclerotic plaque morphology as assessed by OCT.
Read the detailed description
Following initial percutaneous coronary intervention (PCI) for culprit lesions in patients with early-onset coronary artery disease (CAD) and ≥2 additional lesions meeting baseline lipid criteria, optical coherence tomography (OCT) was employed to evaluate non-culprit lesion sites for detailed characterization of plaque features including calcification, fibrosis, fibrolipid deposition, necrosis, minimum fibrous cap thickness (mFCT), and maximum lipid arc (MLA). Subsequently, patients were randomized in a 1:1 ratio to receive either intensive statin therapy alone or a combination of PCSK9 inhibitor with moderate-intensity statin therapy, using a random number allocation method. After 1 year of treatment and follow-up, OCT reassessment of non-culprit vessel critical lesions was conducted, documenting plaque characteristics such as calcification, fibrosis, fibrolipid content, necrosis, as well as stability parameters like mFCT and MLA at lesion sites. OCT findings were compared longitudinally within each treatment group and between groups receiving PCSK9 inhibitor combined with statin therapy versus intensive statin therapy alone. Baseline clinical profiles, biochemical markers, imaging findings, and incidence of adverse cardiovascular events during the follow-up period were also meticulously recorded for all enrolled early-onset CAD patients.
- Being tested
- PCSK9 inhibitor, Statin
- Keywords
- Coronary Artery Disease, Lipid-lowering Therapy, PCSK9, Optical Coherence Tomography
- 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.
PCSK9 inhibitorDrug
PCSK9 inhibitors combined with moderate-intensity statin therapy
StatinDrug
Intensive statin therapy
| Study group | Role | What they receive |
|---|---|---|
| PCSK9 inhibitor group | Experimental | PCSK9 Inhibitors Combined with Moderate-Intensity Statin Therapy Receives: Drug: PCSK9 inhibitor |
| Intensive statin group | Other | Intensive statin therapy Receives: Drug: Statin |
What is being measured
The primary outcome is the main question the study is designed to answer.
mFCT
minimum fibrous cap thickness
Measured: Immediate and 1 year after PCI
MLA
maximum lipid arc
Measured: Immediate and 1 year after PCI
Calcification
calcification
Measured: Immediate and 1 year after PCI
Fibrosis
fibrosis
Measured: Immediate and 1 year after PCI
Fibrolipid deposition
fibrolipid deposition
Measured: Immediate and 1 year after PCI
Necrosis
necrosis
Measured: Immediate and 1 year after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start1 Jul 2024
- Primary completion30 Sep 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 (14)Papers the sponsor has linked to this study.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 396 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Xinjiang Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhenyan Fu, PHD, First Affiliated Hospital of Xinjiang Medical University
- Investigators
- Zhenyan Fu, PhD, Principal investigator, First Affiliated Hospital of Xinjiang Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520904
- Sponsor's protocol ID
- EPCAP-OCT
- Status last verified
- Aug 2024
- First submitted
- 20 Jul 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be made available on reasonable request to the official agencies.
Publications
Johnson TW, Raber L, di Mario C, Bourantas C, Jia H, Mattesini A, Gonzalo N, de la Torre Hernandez JM, Prati F, Koskinas K, Joner M, Radu MD, Erlinge D, Regar E, Kunadian V, Maehara A, Byrne RA, Capodanno D, Akasaka T, Wijns W, Mintz GS, Guagliumi G. Clinical use of intracoronary imaging. Part 2: acute coronary syndromes, ambiguous coronary angiography findings, and guiding interventional decision-making: an expert consensus document of the European Association of Percutaneous Cardiovascular Interventions. Eur Heart J. 2019 Aug 14;40(31):2566-2584. doi: 10.1093/eurheartj/ehz332.
PubMed 31112213Mortensen MB, Dzaye O, Steffensen FH, Botker HE, Jensen JM, Ronnow Sand NP, Kragholm KH, Sorensen HT, Leipsic J, Maeng M, Blaha MJ, Norgaard BL. Impact of Plaque Burden Versus Stenosis on Ischemic Events in Patients With Coronary Atherosclerosis. J Am Coll Cardiol. 2020 Dec 15;76(24):2803-2813. doi: 10.1016/j.jacc.2020.10.021.
PubMed 33303068Taron J, Foldyna B, Mayrhofer T, Osborne MT, Meyersohn N, Bittner DO, Puchner SB, Emami H, Lu MT, Ferencik M, Pagidipati NJ, Douglas PS, Hoffmann U. Risk Stratification With the Use of Coronary Computed Tomographic Angiography in Patients With Nonobstructive Coronary Artery Disease. JACC Cardiovasc Imaging. 2021 Nov;14(11):2186-2195. doi: 10.1016/j.jcmg.2021.03.019. Epub 2021 Apr 14.
PubMed 33865792Koskinas KC, Ughi GJ, Windecker S, Tearney GJ, Raber L. Intracoronary imaging of coronary atherosclerosis: validation for diagnosis, prognosis and treatment. Eur Heart J. 2016 Feb 7;37(6):524-35a-c. doi: 10.1093/eurheartj/ehv642. Epub 2015 Dec 11.
PubMed 26655874Prati F, Romagnoli E, Gatto L, La Manna A, Burzotta F, Ozaki Y, Marco V, Boi A, Fineschi M, Fabbiocchi F, Taglieri N, Niccoli G, Trani C, Versaci F, Calligaris G, Ruscica G, Di Giorgio A, Vergallo R, Albertucci M, Biondi-Zoccai G, Tamburino C, Crea F, Alfonso F, Arbustini E. Relationship between coronary plaque morphology of the left anterior descending artery and 12 months clinical outcome: the CLIMA study. Eur Heart J. 2020 Jan 14;41(3):383-391. doi: 10.1093/eurheartj/ehz520.
PubMed 31504405Erlinge D, Maehara A, Ben-Yehuda O, Botker HE, Maeng M, Kjoller-Hansen L, Engstrom T, Matsumura M, Crowley A, Dressler O, Mintz GS, Frobert O, Persson J, Wiseth R, Larsen AI, Okkels Jensen L, Nordrehaug JE, Bleie O, Omerovic E, Held C, James SK, Ali ZA, Muller JE, Stone GW; PROSPECT II Investigators. Identification of vulnerable plaques and patients by intracoronary near-infrared spectroscopy and ultrasound (PROSPECT II): a prospective natural history study. Lancet. 2021 Mar 13;397(10278):985-995. doi: 10.1016/S0140-6736(21)00249-X.
PubMed 33714389Raber L, Koskinas KC, Yamaji K, Taniwaki M, Roffi M, Holmvang L, Garcia Garcia HM, Zanchin T, Maldonado R, Moschovitis A, Pedrazzini G, Zaugg S, Dijkstra J, Matter CM, Serruys PW, Luscher TF, Kelbaek H, Karagiannis A, Radu MD, Windecker S. Changes in Coronary Plaque Composition in Patients With Acute Myocardial Infarction Treated With High-Intensity Statin Therapy (IBIS-4): A Serial Optical Coherence Tomography Study. JACC Cardiovasc Imaging. 2019 Aug;12(8 Pt 1):1518-1528. doi: 10.1016/j.jcmg.2018.08.024. Epub 2018 Dec 12.
PubMed 30553686Mach F, Baigent C, Catapano AL, Koskinas KC, Casula M, Badimon L, Chapman MJ, De Backer GG, Delgado V, Ference BA, Graham IM, Halliday A, Landmesser U, Mihaylova B, Pedersen TR, Riccardi G, Richter DJ, Sabatine MS, Taskinen MR, Tokgozoglu L, Wiklund O; ESC Scientific Document Group. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. Eur Heart J. 2020 Jan 1;41(1):111-188. doi: 10.1093/eurheartj/ehz455. No abstract available.
PubMed 31504418Koskinas KC, Gencer B, Nanchen D, Branca M, Carballo D, Klingenberg R, Blum MR, Carballo S, Muller O, Matter CM, Luscher TF, Rodondi N, Heg D, Wilhelm M, Raber L, Mach F, Windecker S. Eligibility for PCSK9 inhibitors based on the 2019 ESC/EAS and 2018 ACC/AHA guidelines. Eur J Prev Cardiol. 2021 Mar 23;28(1):59-65. doi: 10.1177/2047487320940102. Epub 2020 Jul 20.
PubMed 33755142Nicholls SJ, Puri R, Anderson T, Ballantyne CM, Cho L, Kastelein JJ, Koenig W, Somaratne R, Kassahun H, Yang J, Wasserman SM, Scott R, Ungi I, Podolec J, Ophuis AO, Cornel JH, Borgman M, Brennan DM, Nissen SE. Effect of Evolocumab on Progression of Coronary Disease in Statin-Treated Patients: The GLAGOV Randomized Clinical Trial. JAMA. 2016 Dec 13;316(22):2373-2384. doi: 10.1001/jama.2016.16951.
PubMed 27846344Nicholls SJ, Kataoka Y, Nissen SE, Prati F, Windecker S, Puri R, Hucko T, Aradi D, Herrman JR, Hermanides RS, Wang B, Wang H, Butters J, Di Giovanni G, Jones S, Pompili G, Psaltis PJ. Effect of Evolocumab on Coronary Plaque Phenotype and Burden in Statin-Treated Patients Following Myocardial Infarction. JACC Cardiovasc Imaging. 2022 Jul;15(7):1308-1321. doi: 10.1016/j.jcmg.2022.03.002. Epub 2022 Mar 16.
PubMed 35431172Raber L, Ueki Y, Otsuka T, Losdat S, Haner JD, Lonborg J, Fahrni G, Iglesias JF, van Geuns RJ, Ondracek AS, Radu Juul Jensen MD, Zanchin C, Stortecky S, Spirk D, Siontis GCM, Saleh L, Matter CM, Daemen J, Mach F, Heg D, Windecker S, Engstrom T, Lang IM, Koskinas KC; PACMAN-AMI collaborators. Effect of Alirocumab Added to High-Intensity Statin Therapy on Coronary Atherosclerosis in Patients With Acute Myocardial Infarction: The PACMAN-AMI Randomized Clinical Trial. JAMA. 2022 May 10;327(18):1771-1781. doi: 10.1001/jama.2022.5218.
PubMed 35368058Gao F, Wang ZJ, Ma XT, Shen H, Yang LX, Zhou YJ. Effect of alirocumab on coronary plaque in patients with coronary artery disease assessed by optical coherence tomography. Lipids Health Dis. 2021 Sep 12;20(1):106. doi: 10.1186/s12944-021-01528-3.
PubMed 34511134Liu S, Wang P, Liu C, Jin M, Wan J, Hou J, Yang Y, Wang D, Liu Z, Fu Z. Effect of PCSK9 antibodies on coronary plaque regression and stabilization derived from intravascular imaging in patients with coronary artery disease: A meta-analysis. Int J Cardiol. 2023 Dec 1;392:131330. doi: 10.1016/j.ijcard.2023.131330. Epub 2023 Sep 4.
PubMed 37666281
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of PCSK9 Inhibitors on Coronary Atherosclerotic Plaques Derived From Optical Coherence Tomography in Patients With Premature Coronary Artery Disease: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06520904
- Acronym / sponsor ID
- EPCAP-OCT
- Keywords
- Coronary Artery Disease, Lipid-lowering Therapy, PCSK9, Optical Coherence Tomography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 396 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Xinjiang Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Jul 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.
The presence of coronary atherosclerotic vulnerable plaque significantly impacts the clinical outcomes of patients diagnosed with coronary artery disease (CAD). However, the influence of PCSK9 inhibitors on stabilizing coronary atherosclerotic plaques in individuals with early-onset CAD, evaluated through optical coherence tomography (OCT), remains inadequately understood. Moreover, there is a notable absence of relevant randomized controlled trials investigating this phenomenon. This current study represents a single-center, randomized, controlled, open-label trial conducted among Asian patients with early-onset CAD. Its principal objective was to explore the effects of PCSK9 inhibitors on coronary atherosclerotic plaque morphology as assessed by OCT.
Detailed description
Following initial percutaneous coronary intervention (PCI) for culprit lesions in patients with early-onset coronary artery disease (CAD) and ≥2 additional lesions meeting baseline lipid criteria, optical coherence tomography (OCT) was employed to evaluate non-culprit lesion sites for detailed characterization of plaque features including calcification, fibrosis, fibrolipid deposition, necrosis, minimum fibrous cap thickness (mFCT), and maximum lipid arc (MLA). Subsequently, patients were randomized in a 1:1 ratio to receive either intensive statin therapy alone or a combination of PCSK9 inhibitor with moderate-intensity statin therapy, using a random number allocation method. After 1 year of treatment and follow-up, OCT reassessment of non-culprit vessel critical lesions was conducted, documenting plaque characteristics such as calcification, fibrosis, fibrolipid content, necrosis, as well as stability parameters like mFCT and MLA at lesion sites. OCT findings were compared longitudinally within each treatment group and between groups receiving PCSK9 inhibitor combined with statin therapy versus intensive statin therapy alone. Baseline clinical profiles, biochemical markers, imaging findings, and incidence of adverse cardiovascular events during the follow-up period were also meticulously recorded for all enrolled early-onset CAD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCSK9 inhibitor group | Experimental | Drug: PCSK9 inhibitorPCSK9 Inhibitors Combined with Moderate-Intensity Statin Therapy |
| Intensive statin group | Other | Drug: StatinIntensive statin therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men aged 18-55 years and women aged 18-65 years;
- CAD patients with coronary angiographically confirmed lesions in ≥2 vessels; at least one vessel was critically diseased (50-70% stenosis level);
- LDL-C >3.4 mmol/L without regular statin therapy or LDL-C >1.8 mmol/L after 4 weeks of statin lipid-lowering therapy.
Key exclusion criteria (11 listed)
- Known allergies or contraindications to PCSK9 inhibitors and/or statin therapy;
- Prior use of PCSK9 inhibitors;
- Prior history of hemorrhagic stroke;
- Prior coronary artery bypass grafting or coronary intervention;
- Inability to perform OCT imaging or unclear imaging;
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 inhibitorPCSK9 inhibitors combined with moderate-intensity statin therapy | Drug | PCSK9 inhibitor group |
| StatinIntensive statin therapy | Drug | Intensive statin group |
Primary outcome
mFCT
Time frame: Immediate and 1 year after PCI
minimum fibrous cap thickness
MLA
Time frame: Immediate and 1 year after PCI
maximum lipid arc
Calcification
Time frame: Immediate and 1 year after PCI
calcification
Fibrosis
Time frame: Immediate and 1 year after PCI
fibrosis
Fibrolipid deposition
Time frame: Immediate and 1 year after PCI
fibrolipid deposition
Necrosis
Time frame: Immediate and 1 year after PCI
necrosis
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 19 Aug 2024.
- Background: PubMed 31112213Johnson TW, Raber L, di Mario C, Bourantas C, Jia H, Mattesini A, Gonzalo N, de la Torre Hernandez JM, Prati F, Koskinas K, Joner M, Radu MD, Erlinge D, Regar E, Kunadian V, Maehara A, Byrne RA, Capodanno D, Akasaka T, Wijns W, Mintz GS, Guagliumi G. Clinical use of intracoronary imaging. Part 2: acute coronary syndromes, ambiguous coronary angiography findings, and guiding interventional decision-making: an expert consensus document of the European Association of Percutaneous Cardiovascular Interventions. Eur Heart J. 2019 Aug 14;40(31):2566-2584. doi: 10.1093/eurheartj/ehz332.
- Background: PubMed 33303068Mortensen MB, Dzaye O, Steffensen FH, Botker HE, Jensen JM, Ronnow Sand NP, Kragholm KH, Sorensen HT, Leipsic J, Maeng M, Blaha MJ, Norgaard BL. Impact of Plaque Burden Versus Stenosis on Ischemic Events in Patients With Coronary Atherosclerosis. J Am Coll Cardiol. 2020 Dec 15;76(24):2803-2813. doi: 10.1016/j.jacc.2020.10.021.
- Background: PubMed 33865792Taron J, Foldyna B, Mayrhofer T, Osborne MT, Meyersohn N, Bittner DO, Puchner SB, Emami H, Lu MT, Ferencik M, Pagidipati NJ, Douglas PS, Hoffmann U. Risk Stratification With the Use of Coronary Computed Tomographic Angiography in Patients With Nonobstructive Coronary Artery Disease. JACC Cardiovasc Imaging. 2021 Nov;14(11):2186-2195. doi: 10.1016/j.jcmg.2021.03.019. Epub 2021 Apr 14.
- Background: PubMed 26655874Koskinas KC, Ughi GJ, Windecker S, Tearney GJ, Raber L. Intracoronary imaging of coronary atherosclerosis: validation for diagnosis, prognosis and treatment. Eur Heart J. 2016 Feb 7;37(6):524-35a-c. doi: 10.1093/eurheartj/ehv642. Epub 2015 Dec 11.
- Background: PubMed 31504405Prati F, Romagnoli E, Gatto L, La Manna A, Burzotta F, Ozaki Y, Marco V, Boi A, Fineschi M, Fabbiocchi F, Taglieri N, Niccoli G, Trani C, Versaci F, Calligaris G, Ruscica G, Di Giorgio A, Vergallo R, Albertucci M, Biondi-Zoccai G, Tamburino C, Crea F, Alfonso F, Arbustini E. Relationship between coronary plaque morphology of the left anterior descending artery and 12 months clinical outcome: the CLIMA study. Eur Heart J. 2020 Jan 14;41(3):383-391. doi: 10.1093/eurheartj/ehz520.
- Background: PubMed 33714389Erlinge D, Maehara A, Ben-Yehuda O, Botker HE, Maeng M, Kjoller-Hansen L, Engstrom T, Matsumura M, Crowley A, Dressler O, Mintz GS, Frobert O, Persson J, Wiseth R, Larsen AI, Okkels Jensen L, Nordrehaug JE, Bleie O, Omerovic E, Held C, James SK, Ali ZA, Muller JE, Stone GW; PROSPECT II Investigators. Identification of vulnerable plaques and patients by intracoronary near-infrared spectroscopy and ultrasound (PROSPECT II): a prospective natural history study. Lancet. 2021 Mar 13;397(10278):985-995. doi: 10.1016/S0140-6736(21)00249-X.
- Background: PubMed 30553686Raber L, Koskinas KC, Yamaji K, Taniwaki M, Roffi M, Holmvang L, Garcia Garcia HM, Zanchin T, Maldonado R, Moschovitis A, Pedrazzini G, Zaugg S, Dijkstra J, Matter CM, Serruys PW, Luscher TF, Kelbaek H, Karagiannis A, Radu MD, Windecker S. Changes in Coronary Plaque Composition in Patients With Acute Myocardial Infarction Treated With High-Intensity Statin Therapy (IBIS-4): A Serial Optical Coherence Tomography Study. JACC Cardiovasc Imaging. 2019 Aug;12(8 Pt 1):1518-1528. doi: 10.1016/j.jcmg.2018.08.024. Epub 2018 Dec 12.
- Background: PubMed 31504418Mach F, Baigent C, Catapano AL, Koskinas KC, Casula M, Badimon L, Chapman MJ, De Backer GG, Delgado V, Ference BA, Graham IM, Halliday A, Landmesser U, Mihaylova B, Pedersen TR, Riccardi G, Richter DJ, Sabatine MS, Taskinen MR, Tokgozoglu L, Wiklund O; ESC Scientific Document Group. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. Eur Heart J. 2020 Jan 1;41(1):111-188. doi: 10.1093/eurheartj/ehz455. No abstract available.
- Background: PubMed 33755142Koskinas KC, Gencer B, Nanchen D, Branca M, Carballo D, Klingenberg R, Blum MR, Carballo S, Muller O, Matter CM, Luscher TF, Rodondi N, Heg D, Wilhelm M, Raber L, Mach F, Windecker S. Eligibility for PCSK9 inhibitors based on the 2019 ESC/EAS and 2018 ACC/AHA guidelines. Eur J Prev Cardiol. 2021 Mar 23;28(1):59-65. doi: 10.1177/2047487320940102. Epub 2020 Jul 20.
- Background: PubMed 27846344Nicholls SJ, Puri R, Anderson T, Ballantyne CM, Cho L, Kastelein JJ, Koenig W, Somaratne R, Kassahun H, Yang J, Wasserman SM, Scott R, Ungi I, Podolec J, Ophuis AO, Cornel JH, Borgman M, Brennan DM, Nissen SE. Effect of Evolocumab on Progression of Coronary Disease in Statin-Treated Patients: The GLAGOV Randomized Clinical Trial. JAMA. 2016 Dec 13;316(22):2373-2384. doi: 10.1001/jama.2016.16951.
- Background: PubMed 35431172Nicholls SJ, Kataoka Y, Nissen SE, Prati F, Windecker S, Puri R, Hucko T, Aradi D, Herrman JR, Hermanides RS, Wang B, Wang H, Butters J, Di Giovanni G, Jones S, Pompili G, Psaltis PJ. Effect of Evolocumab on Coronary Plaque Phenotype and Burden in Statin-Treated Patients Following Myocardial Infarction. JACC Cardiovasc Imaging. 2022 Jul;15(7):1308-1321. doi: 10.1016/j.jcmg.2022.03.002. Epub 2022 Mar 16.
- Background: PubMed 35368058Raber L, Ueki Y, Otsuka T, Losdat S, Haner JD, Lonborg J, Fahrni G, Iglesias JF, van Geuns RJ, Ondracek AS, Radu Juul Jensen MD, Zanchin C, Stortecky S, Spirk D, Siontis GCM, Saleh L, Matter CM, Daemen J, Mach F, Heg D, Windecker S, Engstrom T, Lang IM, Koskinas KC; PACMAN-AMI collaborators. Effect of Alirocumab Added to High-Intensity Statin Therapy on Coronary Atherosclerosis in Patients With Acute Myocardial Infarction: The PACMAN-AMI Randomized Clinical Trial. JAMA. 2022 May 10;327(18):1771-1781. doi: 10.1001/jama.2022.5218.
- Individual participant dataSharing planned: No. IPD will be made available on reasonable request to the official agencies.
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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.
Zhenyan Fu, PhD principal investigator
First Affiliated Hospital of Xinjiang Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PCSK9 inhibitor and Statin in people with Coronary Artery Disease and Optical Coherence Tomography, run by First Affiliated Hospital of Xinjiang Medical University at 1 site 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 3 inclusion and 11 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 19 Aug 2024. 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 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Sen Liu, MD (09914366872 ext. +86, 463387160@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mFCT (time frame: Immediate and 1 year after PCI). The study lists 6 primary outcomes in all. 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 NCT06520904, which also lists 14 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 19 Aug 2024.