In-stent RestenosisPhase 4NCT05623995
Effect of Evolocumab on Chronic Total Occlusions (EVOLO-CTO)
A Phase 4 study testing PCSK9 inhibitor and Statin in people with In-stent Restenosis and Major Adverse Cardiovascular Events, run by Lin Zhao at 1 site in China.
Trial summary
The purpose of this study is to evaluate the effect of proprotein convertase subtilisin/kexin type-9 (PCSK9) inhibitors added to regular statin therapy on target lesion failure (TLF) and arteriosclerosis progression in patients with chronic total occlusions (CTOs) undergoing successful percutaneous coronary… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- In-stent Restenosis, Major Adverse Cardiovascular Events
- What is being tested?
- PCSK9 inhibitor and Statin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2022to 1 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age with written informed consent
- Presence of a CTO in native coronary artery.
- Stable angina or myocardial ischemia in a territory supplied by CTO
- CTO located in segments 1-3 (RCA), 6-7 (LAD), 11-12 (LCx)
- Target artery ≥2.5mm
- Scheduled to undergo percutaneous coronary intervention (PCI)
- LDL-C ≥70 mg/dL (≥1.8 mmol/L) in patients who have been on any stable statin regimen for ≥ 4 weeks prior to enrollment; or LDL-C ≥125 mg/dL (≥3.2 mmol/L) in patients who are statin-naïve or have not been receiving stable statin regimen for ≥ 4 weeks prior to enrollment
Who cannot join
- Acute myocardial infarction within 1 month
- Known severe chronic kidney disease (estimated Glomerular Filtration Rate [eGFR] <60 mL/min/1.73m2 or serum creatinine level >2.5 mg/dL);
- History of allergy to iodine contrast agents
- Allergy to PCSK9 inhibitors or any other ingredients contained in study drug
- Pregnancy or breastfeeding
- Persistent or permanent atrial fibrillation
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- Patients with history of coronary artery bypass graft
- Inability or unwilling to provide informed consent
- Malignant neoplasms or Major illness with life expectancy <1 year
- Planned coronary revascularization or major non-cardiac surgery 12 months after intervention
- Patients previously treated with PCSK9 inhibitors.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029
Xu Wang, MD, +86 15311765609, huaianwangxu@126.com
About this study
Official title: Effect of Evolocumab on Chronic Total Occlusions After Successful Percutaneous Coronary Intervention (EVOLO-CTO)
The purpose of this study is to evaluate the effect of proprotein convertase subtilisin/kexin type-9 (PCSK9) inhibitors added to regular statin therapy on target lesion failure (TLF) and arteriosclerosis progression in patients with chronic total occlusions (CTOs) undergoing successful percutaneous coronary intervention (PCI).
Read the detailed description
Chronic total occlusions (CTOs) are found in 15-25% of patients with stable angina pectoris. The presence of a CTO indicates unfavorable prognosis, with higher rate of major adverse cardiovascular events. Statins are frequently used after PCI in order to lower LDL cholesterol levels and reduce the chances of coronary artery obstruction recurring. Despite this preventive measure, high risk for restenosis and re-occlusion was observed a significant proportion of patients with CTOs undergoing PCI.
Proprotein convertase subtilisin/kexin type-9 (PCSK9) inhibitors represent a novel class of lipid-lowering drugs leading to rapid, profound, and consistent reductions in LDL-C levels. The effect of PCSK9 inhibitor in patients with CTO, after a recent PCI is not known.
In this study the investigators want to evaluate the effect of the PCSK9 inhibitor on neointimal hyperplasia and target lesion failure (TLF) in patients with CTOs receiving regular statin treatment. A serial of intravascular ultrasound imaging study will be performed to determine the arteriosclerosis progression at 48 weeks.
- Being tested
- PCSK9 inhibitor, Statin
- Keywords
- Chronic total occlusion, Restenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCSK9 inhibitorDrug
Also called Evolocumab
Evolocumab per every two weeks, starting at day 1 and up to week 48, added to guideline recommended statin therapy..
StatinDrug
Also called Hydroxymethylglutaryl-Coenzyme A Reductase inhibitor
Guideline recommended statin therapy.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Participants will receive PCSK9 inhibitors added to guideline recommended statin therapy. Receives: Drug: PCSK9 inhibitor |
| Control arm | Active comparator | Patients will continue to taking guideline recommended statin therapy. Receives: Drug: Statin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percent plaque volume and plaque burden.
Change in percent plaque volume and plaque burden by intravascular ultrasound (IVUS) between PCSK9 inhibitors group and control group.
Measured: 12 months
Secondary outcomes (4)
Rate of Target Lesion Failure (TLF)
TLF is defined as a composite of: all cardiac death, target vessel myocardial infarction (SCAI definition), and clinically driven target lesion revascularization (TLR).
Measured: 12 months
Neointimal volume with intravascular ultrasound (IVUS) (mm3 per 1mm)
Comparison of neointima volume by IVUS between PCSK9 inhibitors group and control group.
Measured: 12 months
Ischemia
Ischemic burden assessed with CMR from baseline to 3 and 12 months follow-up
Measured: 12 months
Change in left ventricular systolic function assessed with CMR
The left ventricular ejection fraction assessed with CMR from baseline to 3 and 12 months follow up
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start15 Dec 2022
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In-stent RestenosisStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lin Zhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lin Zhao, Beijing Anzhen Hospital
- Investigators
- Lin Zhao, MD, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623995
- Sponsor's protocol ID
- 2022-22
- Status last verified
- Nov 2023
- First submitted
- 7 Nov 2022
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Evolocumab on Chronic Total Occlusions After Successful Percutaneous Coronary Intervention (EVOLO-CTO)
- ClinicalTrials.gov ID
- NCT05623995
- Acronym / sponsor ID
- 2022-22
- Keywords
- Chronic total occlusion, Restenosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Lin ZhaoUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 21 Nov 2022 (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 purpose of this study is to evaluate the effect of proprotein convertase subtilisin/kexin type-9 (PCSK9) inhibitors added to regular statin therapy on target lesion failure (TLF) and arteriosclerosis progression in patients with chronic total occlusions (CTOs) undergoing successful percutaneous coronary intervention (PCI).
Detailed description
Chronic total occlusions (CTOs) are found in 15-25% of patients with stable angina pectoris. The presence of a CTO indicates unfavorable prognosis, with higher rate of major adverse cardiovascular events. Statins are frequently used after PCI in order to lower LDL cholesterol levels and reduce the chances of coronary artery obstruction recurring. Despite this preventive measure, high risk for restenosis and re-occlusion was observed a significant proportion of patients with CTOs undergoing PCI.
Proprotein convertase subtilisin/kexin type-9 (PCSK9) inhibitors represent a novel class of lipid-lowering drugs leading to rapid, profound, and consistent reductions in LDL-C levels. The effect of PCSK9 inhibitor in patients with CTO, after a recent PCI is not known.
In this study the investigators want to evaluate the effect of the PCSK9 inhibitor on neointimal hyperplasia and target lesion failure (TLF) in patients with CTOs receiving regular statin treatment. A serial of intravascular ultrasound imaging study will be performed to determine the arteriosclerosis progression at 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: PCSK9 inhibitorParticipants will receive PCSK9 inhibitors added to guideline recommended statin therapy. |
| Control arm | Active comparator | Drug: StatinPatients will continue to taking guideline recommended statin therapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 18 years of age with written informed consent
- Presence of a CTO in native coronary artery.
- Stable angina or myocardial ischemia in a territory supplied by CTO
- CTO located in segments 1-3 (RCA), 6-7 (LAD), 11-12 (LCx)
- Target artery ≥2.5mm
Key exclusion criteria (11 listed)
- Acute myocardial infarction within 1 month
- Known severe chronic kidney disease (estimated Glomerular Filtration Rate [eGFR] <60 mL/min/1.73m2 or serum creatinine level >2.5 mg/dL);
- History of allergy to iodine contrast agents
- Allergy to PCSK9 inhibitors or any other ingredients contained in study drug
- Pregnancy or breastfeeding
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 inhibitorAlso: EvolocumabEvolocumab per every two weeks, starting at day 1 and up to week 48, added to guideline recommended statin therapy.. | Drug | Treatment arm |
| StatinAlso: Hydroxymethylglutaryl-Coenzyme A Reductase inhibitorGuideline recommended statin therapy. | Drug | Control arm |
Primary outcome
Change in percent plaque volume and plaque burden.
Time frame: 12 months
Change in percent plaque volume and plaque burden by intravascular ultrasound (IVUS) between PCSK9 inhibitors group and control group.
4 secondary outcomes
Rate of Target Lesion Failure (TLF)
Time frame: 12 months
Neointimal volume with intravascular ultrasound (IVUS) (mm3 per 1mm)
Time frame: 12 months
Ischemia
Time frame: 12 months
Change in left ventricular systolic function assessed with CMR
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Lin Zhao, MD principal investigator
Beijing Anzhen Hospital
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 In-stent Restenosis and Major Adverse Cardiovascular Events, run by Lin Zhao 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 7 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: status not confirmed, as of the sponsor's last update on 13 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xu Wang, MD (+8615311765609, huaianwangxu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in percent plaque volume and plaque burden. (time frame: 12 months). 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 13 Nov 2023.