Coronary Heart Disease Clinical Trial
Official title:
A Double Blind, Randomized Study to Compare Influence of Niacin/Laropiprant on Functional and Morphological Characteristics of Arterial Wall and Parameters of Inflammation in Subjects With Coronary Heart Disease Already Treated With a Statin
Verified date | October 2011 |
Source | University Medical Centre Ljubljana |
Contact | n/a |
Is FDA regulated | No |
Health authority | Slovenia: Ethics Committee |
Study type | Interventional |
Primary objective:
To evaluate the impact of 12 weeks' administration of extended release niacin/laropiprant
(ERN/LRPT) compared to placebo added to statin therapy on endothelial dependant dilatation
of the arterial wall assessed by brachial vasoreactivity in stable coronary heart disease
(CHD) patients.
Secondary objective:
To evaluate the impact of 12 weeks' administration of extended release niacin/laropiprant
(ERN/LRPT) compared to placebo added to statin therapy on serum lipids and the parameters of
inflammation in stable coronary heart disease (CHD) patients.
CHD-coronary heart disease ER-extended release
Status | Completed |
Enrollment | 60 |
Est. completion date | October 2011 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 35 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Age 35-55 - Confirmed CHD (post MI patients, coronarography and/or cycloergometer) - Already treated for dyslipidemia with a statin and reaching ESC LDL target - HDL-C <1.1 mmol/l, TG > 1,7 mmol/l and LDL < 2,6 mmol/L - Will be enrolled into the trial Exclusion Criteria: - 3x increase of liver enzyme tests or CK - Severe renal insufficiency - creatinin >200 mmol/l - Acute disease within 6 weeks prior to inclusion - Hypersensitivity to nicotinic acid - Other cardiac medication stable for at least 4 weeks prior to enrollment - Acute MI, CABG, PCI within past 3 months - Congestive heart failure (CHF) _ NYHA 2 - Ejection fraction < 40% measured within the past 6 months - Malignancy - HIV infection or immunodeficiency state - Stable dose of statin < 6 weeks - Diabetes mellitus type 1 - Diabetes mellitus type 2 with HbA1C > 7% - Hypo/hyper thyroidism - Alcohol or drug abuse |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Slovenia | UMC Ljubljana | Ljubljana |
Lead Sponsor | Collaborator |
---|---|
University Medical Centre Ljubljana |
Slovenia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the impact of 12 weeks' administration of extended release niacin/laropiprant (ERN/LRPT) compared to placebo added to statin therapy on endothelial dependant dilatation of the arterial wall assessed by brachial vasoreactivity | Ultrasound measurement of endothelial dependent brachial artery dilation before and after treatment will be performed in all patients. | 12 weeks | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05196659 -
Collaborative Quality Improvement (C-QIP) Study
|
N/A | |
Completed |
NCT05088291 -
Application of a New X-ray Protective Device in Coronary Interventional Therapy
|
||
Completed |
NCT03076801 -
Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease?
|
N/A | |
Completed |
NCT04584645 -
A Digital Flu Intervention for People With Cardiovascular Conditions
|
N/A | |
Not yet recruiting |
NCT04995159 -
Optimized Antiplatelet Therapy in Patients With CHD After Implantation of NeoVas™ BRS System
|
N/A | |
Recruiting |
NCT02967718 -
Innovation Research of Differentiation and Treatment Methods Based on CHD Phlegm and Blood Stasis Syndrome
|
N/A | |
Completed |
NCT02888652 -
Study on the Registration of Coronary Heart Disease Patients Undergoing PCI
|
||
Terminated |
NCT02045134 -
Supplementation With Polyphenol-Rich Foods and Atrial Fibrillation After a Cardiac Surgery
|
N/A | |
Completed |
NCT02163044 -
The Hellenic Postprandial Lipemia Study (HPLS)
|
||
Active, not recruiting |
NCT02244853 -
Heart Rate and Cardiovascular Diseases Prognosis in People With Stable Coronary Artery Disease
|
N/A | |
Completed |
NCT01920009 -
Impact of Motivational Interviews Within Pharmacy Care Upon Adherence to Cardiovascular Medicines
|
N/A | |
Completed |
NCT02753829 -
Home-based Cardiovascular Rehabilitation, Maintenance Phase, in Subjects With Coronary Artery Disease
|
N/A | |
Terminated |
NCT01906957 -
Cognition and Exercise Training
|
N/A | |
Completed |
NCT02440893 -
Understanding the Effect of Metformin on Corus CAD (or ASGES)
|
||
Completed |
NCT01826552 -
Comparison of the Angiographic Result of the Orsiro Hybrid Stent With Resolute Integrity Stent
|
Phase 4 | |
Recruiting |
NCT01689688 -
Healing Response to Everolimus-eluting Stent Implantation; Serial Assessment With opticaL Coherence Tomography
|
N/A | |
Completed |
NCT01779401 -
Clopidogrel Response Evaluation and AnTi-Platelet InterVEntion in High Thrombotic Risk PCI Patients
|
N/A | |
Recruiting |
NCT01456364 -
Intracoronary Stenting and Antithrombotic Regimen: ADjusting Antiplatelet Treatment in PatienTs Based on Platelet Function Testing
|
Phase 4 | |
Recruiting |
NCT01462799 -
COR-PRIM: Problem-based Learning (PBL) After Coronary Heart Disease (CHD) - Long-term Evaluation in Primary Care of Self-care
|
N/A | |
Completed |
NCT01428947 -
Does Coronary Angiography Cause Cognitive Dysfunction?
|
N/A |