Coronary Heart DiseaseNCT03771053

The Effect of Simvastatin Combined With Ezetimibe in Patients With Stable Angina and Diabetes

A study testing Ezetimibe with simvastatin and Simvastatin in people with Coronary Heart Disease, run by Chinese PLA General Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Coronary Heart Disease
What is being tested?: Ezetimibe with simvastatin and Simvastatin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 240 participants
Where: 1 siteChina
Study dates: 1 Jan 2018to 31 Dec 2019
Phase: Interventional
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

patients aged 18-75 years
consistent with the Chinese criteria for the diagnosis of chronic stable angina pectoris, stable angina pectoris symptoms in the last three months, and no more than CCS grade 3 of angina pectoris
coronary angiography showed that the degree of coronary artery stenosis was 50% and 70%
LDL-C standard: LDL-C > 80 mg/dL (2.08 mmol/L)
The patients diagnosed with type 2 diabetes were currently using hypoglycemic drugs or insulin
Sign the informed consent to join the group.

Who cannot join

Acute coronary syndromes such as myocardial infarction, unstable angina pectoris, variant angina pectoris, cardiac shock, chronic heart failure, malignant arrhythmia, etc.
Patients requiring stent implantation had been treated with intensive statins prior to admission (e.g. doses of Atto vastatin 40mg or resuvastatin 20mg)
There were contraindications or statins for statin lowering lipids or statins, and there was a history of adverse reactions (liver injury, rash, myolysis, etc.) in the use of Ezeimebum, etc.
Severe liver and kidney dysfunction, creatinine clearance < 30ml / min, acute pancreatitis, malignant tumor, etc.

Trial locations and contacts

1 site in 1 country.

Geng Qian, MD contact

13810914587

qiangeng9396@263.net

China1 site, 1 recruiting

Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, 100853
Geng Qian, MD, 086-01055499312, qiangeng9396@263.net
Yun-dai Chen, MD, 086-01055499309, cyundai@126.com
Recruiting

Other trials in China

About this study

Official title: Intravascular Ultrasound Evaluation of the Intervention Effect of Simvastatin Combined With Ezetimibe on Coronary Borderline Lesion in Patients With Stable Angina Pectoris and Diabetes Mellitus Compared With Simvastatin Alone

In this study, simvastatin combined with Ezeimebum was used to enhance lipid reduction, and IVUS was used to evaluate the volume and composition of coronary plaque before and after treatment. The aim is to evaluate the overall intervention effect of Ezeimebum on stable angina pectoris with diabetes mellitus on the basis of statins.

Read the detailed description

This study was conducted in patients with stable angina pectoris complicated with diabetes mellitus in Chinese PLA General Hospital and coronary arteriography confirmed as critical lesion of coronary artery. The patients were randomly divided into two groups: ezeimebum combined with simvastatin group and simvastatin group. The patients of the former group were given ezeimebum 10mg combined with simvastatin 40mg for 12 months while the patients of the latter group were given simvastatin 40mg for 12 months. Assessed coronary atherosclerotic plaque volume percentage (PAV) and standardized total atherosclerotic plaque volume (TAV) by intravascular ultrasound (IVUS) at the time of entry and out of the group after 12 months. The changes of PAV level in both groups were taken as the main endpoints, and the changes of TAV levels in the two groups as the secondary endpoints. The changes of serum lipids and hypersensitive C-reactive protein levels were compared between the two groups before and after the treatment. Major cardiovascular events (non-fatal myocardial infarction, all-cause death, readmission to acute heart failure, and revascularization of recurrent angina pectoris) were followed up for 12 months.

Conditions: Coronary Heart Disease
Being tested: Ezetimibe with simvastatin, Simvastatin
Keywords: Coronary heart disease, Atherosclerosis, Acute myocardial infarction, Coronary intervention
Medical subject headings: Coronary Disease, Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ezetimibe with simvastatinDrug
ezetimibe 10mg with simvastatin 40mg everyday for 12 months after PCI
SimvastatinDrug
simvastatin 40mg everyday for 12 months after PCI

Study groups in NCT03771053
Study group	Role	What they receive
Ezetimibe with simvastatin group	Experimental	ezetimibe 10mg with simvastatin 40mg everyday for 12 months after PCI Receives: Drug: Ezetimibe with simvastatin
Simvastatin group	Active comparator	simvastatin 40mg everyday for 12 months after PCI Receives: Drug: Simvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from Baseline coronary plaque volume percentage(PAV) at 12 months
PAV=∑（(ESA CSA-lumen CSA)/(ESA CSA)）x100, EEM CSA：cross-sectional area of outer elastic membrane boundary; lumen CSA: cross-sectional area of tube boundary
Measured: 12 months after PCI

Secondary outcomes (6)

Change from Baseline standardized coronary plaque volume(TAV) at 12 months
TAV= (median number of images in ∑ (ESA CSA-lumen CSA) / retracement) x number of images (standardized according to the length of IVUS retracement, To ensure that each individual patient has the same weight)
Measured: 12 months after PCI
LDL-C
Low density lipoprotein cholesterol (LDL-C)
Measured: follow up in one year
HDL-C
High density lipoprotein cholesterol (HDL-C)
Measured: follow up in one year
TG
Total triglyceride(TG)
Measured: follow up in one year
TC
Total cholesterol (TC)
Measured: follow up in one year
Inflammation marker
hs-CRP
Measured: follow up in one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 201831 Dec 2019

First posted10 Dec 2018
Study start1 Jan 2018
Primary completion31 Mar 2019 (estimated)
Study completion31 Dec 2019 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
More trials run by Chinese PLA General HospitalThe 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 240 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03771053
Sponsor's protocol ID: 2017FC-TSYS-3042
Status last verified: Dec 2018
First submitted: 4 Dec 2018
Last updated: 10 Dec 2018
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Zhang X, Khan AA, Haq EU, Rahim A, Hu D, Attia J, Oldmeadow C, Ma X, Ding R, Boyle AJ. Increasing mortality from ischaemic heart disease in China from 2004 to 2010: disproportionate rise in rural areas and elderly subjects. 438 million person-years follow-up. Eur Heart J Qual Care Clin Outcomes. 2017 Jan 1;3(1):47-52. doi: 10.1093/ehjqcco/qcw041.
PubMed 28927191
Emerging Risk Factors Collaboration; Sarwar N, Gao P, Seshasai SR, Gobin R, Kaptoge S, Di Angelantonio E, Ingelsson E, Lawlor DA, Selvin E, Stampfer M, Stehouwer CD, Lewington S, Pennells L, Thompson A, Sattar N, White IR, Ray KK, Danesh J. Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative meta-analysis of 102 prospective studies. Lancet. 2010 Jun 26;375(9733):2215-22. doi: 10.1016/S0140-6736(10)60484-9.
PubMed 20609967
Califf RM, Harrington RA, Blazing MA. Premature release of data from clinical trials of ezetimibe. N Engl J Med. 2009 Aug 13;361(7):712-7. doi: 10.1056/NEJMsr0900910. No abstract available.
PubMed 19675335
Cannon CP, Blazing MA, Giugliano RP, McCagg A, White JA, Theroux P, Darius H, Lewis BS, Ophuis TO, Jukema JW, De Ferrari GM, Ruzyllo W, De Lucca P, Im K, Bohula EA, Reist C, Wiviott SD, Tershakovec AM, Musliner TA, Braunwald E, Califf RM; IMPROVE-IT Investigators. Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes. N Engl J Med. 2015 Jun 18;372(25):2387-97. doi: 10.1056/NEJMoa1410489. Epub 2015 Jun 3.
PubMed 26039521
Stein E, Stender S, Mata P, Sager P, Ponsonnet D, Melani L, Lipka L, Suresh R, Maccubbin D, Veltri E; Ezetimibe Study Group. Achieving lipoprotein goals in patients at high risk with severe hypercholesterolemia: efficacy and safety of ezetimibe co-administered with atorvastatin. Am Heart J. 2004 Sep;148(3):447-55. doi: 10.1016/j.ahj.2004.03.052.
PubMed 15389231
van der Graaf A, Cuffie-Jackson C, Vissers MN, Trip MD, Gagne C, Shi G, Veltri E, Avis HJ, Kastelein JJ. Efficacy and safety of coadministration of ezetimibe and simvastatin in adolescents with heterozygous familial hypercholesterolemia. J Am Coll Cardiol. 2008 Oct 21;52(17):1421-9. doi: 10.1016/j.jacc.2008.09.002.
PubMed 18940534
Nicholls SJ, Sipahi I. Emerging role of intravascular ultrasound in the assessment of experimental anti-atherosclerotic therapies. Curr Med Chem. 2006;13(15):1727-34. doi: 10.2174/092986706777452498.
PubMed 16787216
Nissen SE, Nicholls SJ, Sipahi I, Libby P, Raichlen JS, Ballantyne CM, Davignon J, Erbel R, Fruchart JC, Tardif JC, Schoenhagen P, Crowe T, Cain V, Wolski K, Goormastic M, Tuzcu EM; ASTEROID Investigators. Effect of very high-intensity statin therapy on regression of coronary atherosclerosis: the ASTEROID trial. JAMA. 2006 Apr 5;295(13):1556-65. doi: 10.1001/jama.295.13.jpc60002. Epub 2006 Mar 13.
PubMed 16533939
Nicholls SJ, Borgman M, Nissen SE, Raichlen JS, Ballantyne C, Barter P, Chapman MJ, Erbel R, Libby P. Impact of statins on progression of atherosclerosis: rationale and design of SATURN (Study of Coronary Atheroma by InTravascular Ultrasound: effect of Rosuvastatin versus AtorvastatiN). Curr Med Res Opin. 2011 Jun;27(6):1119-29. doi: 10.1185/03007995.2011.570746. Epub 2011 Mar 30.
PubMed 21446892
Nicholls SJ, Ballantyne CM, Barter PJ, Chapman MJ, Erbel RM, Libby P, Raichlen JS, Uno K, Borgman M, Wolski K, Nissen SE. Effect of two intensive statin regimens on progression of coronary disease. N Engl J Med. 2011 Dec 1;365(22):2078-87. doi: 10.1056/NEJMoa1110874. Epub 2011 Nov 15.
PubMed 22085316

Want to know more?

Geng Qian, MD

13810914587

qiangeng9396@263.net

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intravascular Ultrasound Evaluation of the Intervention Effect of Simvastatin Combined With Ezetimibe on Coronary Borderline Lesion in Patients With Stable Angina Pectoris and Diabetes Mellitus Compared With Simvastatin Alone
ClinicalTrials.gov ID: NCT03771053
Acronym / sponsor ID: 2017FC-TSYS-3042
Conditions: Coronary Heart Disease
Keywords: Coronary heart disease, Atherosclerosis, Acute myocardial infarction, Coronary intervention
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 240 participants (estimated)
Lead sponsor: Chinese PLA General HospitalUniversity, hospital or other
Study start: 1 Jan 2018 (actual)
Primary completion: 31 Mar 2019 (estimated)
Study completion: 31 Dec 2019 (estimated)
First posted: 10 Dec 2018 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Ezetimibe with simvastatin group	Experimental	Drug: Ezetimibe with simvastatinezetimibe 10mg with simvastatin 40mg everyday for 12 months after PCI
Simvastatin group	Active comparator	Drug: Simvastatinsimvastatin 40mg everyday for 12 months after PCI

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

patients aged 18-75 years
consistent with the Chinese criteria for the diagnosis of chronic stable angina pectoris, stable angina pectoris symptoms in the last three months, and no more than CCS grade 3 of angina pectoris
coronary angiography showed that the degree of coronary artery stenosis was 50% and 70%
LDL-C standard: LDL-C > 80 mg/dL (2.08 mmol/L)
The patients diagnosed with type 2 diabetes were currently using hypoglycemic drugs or insulin

Key exclusion criteria (4 listed)

Acute coronary syndromes such as myocardial infarction, unstable angina pectoris, variant angina pectoris, cardiac shock, chronic heart failure, malignant arrhythmia, etc.
Patients requiring stent implantation had been treated with intensive statins prior to admission (e.g. doses of Atto vastatin 40mg or resuvastatin 20mg)
There were contraindications or statins for statin lowering lipids or statins, and there was a history of adverse reactions (liver injury, rash, myolysis, etc.) in the use of Ezeimebum, etc.
Severe liver and kidney dysfunction, creatinine clearance < 30ml / min, acute pancreatitis, malignant tumor, etc.

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
Ezetimibe with simvastatinezetimibe 10mg with simvastatin 40mg everyday for 12 months after PCI	Drug	Ezetimibe with simvastatin group
Simvastatinsimvastatin 40mg everyday for 12 months after PCI	Drug	Simvastatin group

Primary outcome

Change from Baseline coronary plaque volume percentage(PAV) at 12 months
Time frame: 12 months after PCI
PAV=∑（(ESA CSA-lumen CSA)/(ESA CSA)）x100, EEM CSA：cross-sectional area of outer elastic membrane boundary; lumen CSA: cross-sectional area of tube boundary

6 secondary outcomes

Change from Baseline standardized coronary plaque volume(TAV) at 12 months
Time frame: 12 months after PCI
LDL-C
Time frame: follow up in one year
HDL-C
Time frame: follow up in one year
TG
Time frame: follow up in one year
TC
Time frame: follow up in one year
Inflammation marker
Time frame: follow up in one year

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2018.
Background: PubMed 28927191Zhang X, Khan AA, Haq EU, Rahim A, Hu D, Attia J, Oldmeadow C, Ma X, Ding R, Boyle AJ. Increasing mortality from ischaemic heart disease in China from 2004 to 2010: disproportionate rise in rural areas and elderly subjects. 438 million person-years follow-up. Eur Heart J Qual Care Clin Outcomes. 2017 Jan 1;3(1):47-52. doi: 10.1093/ehjqcco/qcw041.
Background: PubMed 20609967Emerging Risk Factors Collaboration; Sarwar N, Gao P, Seshasai SR, Gobin R, Kaptoge S, Di Angelantonio E, Ingelsson E, Lawlor DA, Selvin E, Stampfer M, Stehouwer CD, Lewington S, Pennells L, Thompson A, Sattar N, White IR, Ray KK, Danesh J. Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative meta-analysis of 102 prospective studies. Lancet. 2010 Jun 26;375(9733):2215-22. doi: 10.1016/S0140-6736(10)60484-9.
Background: PubMed 19675335Califf RM, Harrington RA, Blazing MA. Premature release of data from clinical trials of ezetimibe. N Engl J Med. 2009 Aug 13;361(7):712-7. doi: 10.1056/NEJMsr0900910. No abstract available.
Background: PubMed 26039521Cannon CP, Blazing MA, Giugliano RP, McCagg A, White JA, Theroux P, Darius H, Lewis BS, Ophuis TO, Jukema JW, De Ferrari GM, Ruzyllo W, De Lucca P, Im K, Bohula EA, Reist C, Wiviott SD, Tershakovec AM, Musliner TA, Braunwald E, Califf RM; IMPROVE-IT Investigators. Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes. N Engl J Med. 2015 Jun 18;372(25):2387-97. doi: 10.1056/NEJMoa1410489. Epub 2015 Jun 3.
Background: PubMed 15389231Stein E, Stender S, Mata P, Sager P, Ponsonnet D, Melani L, Lipka L, Suresh R, Maccubbin D, Veltri E; Ezetimibe Study Group. Achieving lipoprotein goals in patients at high risk with severe hypercholesterolemia: efficacy and safety of ezetimibe co-administered with atorvastatin. Am Heart J. 2004 Sep;148(3):447-55. doi: 10.1016/j.ahj.2004.03.052.
Background: PubMed 18940534van der Graaf A, Cuffie-Jackson C, Vissers MN, Trip MD, Gagne C, Shi G, Veltri E, Avis HJ, Kastelein JJ. Efficacy and safety of coadministration of ezetimibe and simvastatin in adolescents with heterozygous familial hypercholesterolemia. J Am Coll Cardiol. 2008 Oct 21;52(17):1421-9. doi: 10.1016/j.jacc.2008.09.002.
Background: PubMed 16787216Nicholls SJ, Sipahi I. Emerging role of intravascular ultrasound in the assessment of experimental anti-atherosclerotic therapies. Curr Med Chem. 2006;13(15):1727-34. doi: 10.2174/092986706777452498.
Background: PubMed 16533939Nissen SE, Nicholls SJ, Sipahi I, Libby P, Raichlen JS, Ballantyne CM, Davignon J, Erbel R, Fruchart JC, Tardif JC, Schoenhagen P, Crowe T, Cain V, Wolski K, Goormastic M, Tuzcu EM; ASTEROID Investigators. Effect of very high-intensity statin therapy on regression of coronary atherosclerosis: the ASTEROID trial. JAMA. 2006 Apr 5;295(13):1556-65. doi: 10.1001/jama.295.13.jpc60002. Epub 2006 Mar 13.
Background: PubMed 21446892Nicholls SJ, Borgman M, Nissen SE, Raichlen JS, Ballantyne C, Barter P, Chapman MJ, Erbel R, Libby P. Impact of statins on progression of atherosclerosis: rationale and design of SATURN (Study of Coronary Atheroma by InTravascular Ultrasound: effect of Rosuvastatin versus AtorvastatiN). Curr Med Res Opin. 2011 Jun;27(6):1119-29. doi: 10.1185/03007995.2011.570746. Epub 2011 Mar 30.
Background: PubMed 22085316Nicholls SJ, Ballantyne CM, Barter PJ, Chapman MJ, Erbel RM, Libby P, Raichlen JS, Uno K, Borgman M, Wolski K, Nissen SE. Effect of two intensive statin regimens on progression of coronary disease. N Engl J Med. 2011 Dec 1;365(22):2078-87. doi: 10.1056/NEJMoa1110874. Epub 2011 Nov 15.

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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.

Geng Qian, MD contact

13810914587

qiangeng9396@263.net

Yundai Chen, MD study chair

Chinese PLA General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Ezetimibe with simvastatin and Simvastatin in people with Coronary Heart Disease, run by Chinese PLA General Hospital 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 6 inclusion and 4 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 10 Dec 2018. 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.

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 Geng Qian, MD (13810914587, qiangeng9396@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline coronary plaque volume percentage(PAV) at 12 months (time frame: 12 months after PCI). 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 NCT03771053, which also lists 10 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 10 Dec 2018; AzTrials last refreshed its copy on 7 Nov 2026.