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A Study to Evaluate the Effects of Azilsartan on Coronary Artery Plaque in Essential Hypertensive Patients With Stable Angina and Dyslipidemia. (ALIVE)

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ClinicalTrials.gov Identifier: NCT02400775
Recruitment Status : Withdrawn
First Posted : March 27, 2015
Last Update Posted : May 24, 2016
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this study is to evaluate the effects of oral azilsartan once daily for 32 weeks on coronary artery plaque in essential hypertensive patients with stable angina and dyslipidemia.

Condition or disease Intervention/treatment Phase
Essential Hypertension With Stable Angina and Dyslipidemia Drug: Azilsartan Phase 4

Detailed Description:

The open-label design without a control group was selected because this clinical study primarily aims to explore the effects of azilsartan on coronary artery plaques.

This study targeting patients with coronary artery plaque has been designed to enroll hypertensive patients with dyslipidemia. Also in light of the invasive nature of the major assessment procedures (i.e., IB-IVUS, OCT), this study will only enroll patients with stable angina planned to undergo percutaneous coronary intervention with stent placement, among patients with coronary artery plaque.

The starting dose of azilsartan has been set to 20 mg on the basis of the usual clinical dose of the drug in patients with essential hypertension, and dose increase of azilsartan will be permitted only when the target blood pressure has not been achieved.

The duration of treatment has been set to 32 weeks in line with clinical practice, in which coronary angiography is typically performed after a 32-week follow-up period following PCI with stent placement.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Effects of Azilsartan on Coronary Artery Plaque in Essential Hypertensive Patients With Stable Angina and Dyslipidemia.
Study Start Date : March 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

Arm Intervention/treatment
Experimental: Azilsartan
Azilsartan orally once daily in the morning, either before or after breakfast
Drug: Azilsartan
Azilsartan tablets
Other Name: Azilva tablets




Primary Outcome Measures :
  1. Change in percentage of the lipid pool in the coronary artery plaque [ Time Frame: 32 weeks ]

    Change in percentage of the lipid pool in the coronary artery plaque from the start of the treatment period at the end of the treatment period (Week 32).

    Percentage of the lipid pool in the coronary artery plaque is measured by integrated backscatter intravascular ultrasound (IB-IVUS).



Secondary Outcome Measures :
  1. Change in volume of the coronary artery plaque [ Time Frame: 32 weeks ]

    Change in the volume of the coronary artery plaque from the start of the treatment period to the end of the treatment period.

    Change from baseline in volume of the coronary artery plaque is measured by integrated backscatter intravascular ultrasound (IB-IVUS).


  2. Change in percentage of the fibrotic component in the coronary artery plaque [ Time Frame: 32 weeks ]

    Change in percentage of the fibrotic component in the coronary artery plaque from the start of the treatment period at the end of the treatment period (Week 32).

    Percentage of the fibrotic component in the coronary artery plaque is measured by integrated backscatter intravascular ultrasound (IB-IVUS).


  3. Change in percentage of the calcified component in the coronary artery plaque [ Time Frame: 32 weeks ]

    Change in percentage of the calcified component in the coronary artery plaque from the start of the treatment period at the end of the treatment period (Week 32).

    Percentage of the calcified component in the coronary artery plaque is measured by integrated backscatter intravascular ultrasound (IB-IVUS).


  4. Change in number of microchannels [ Time Frame: 32 weeks ]
    Change from baseline in number of microchannels is measured by Optical Coherence Tomography(OCT).

  5. Change in thickness of the fibrous cap [ Time Frame: 32 weeks ]
    Change from baseline in number of microchannels is measured by Optical Coherence Tomography(OCT).



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with essential hypertension with office blood pressure before the start of study treatment (Week 0) meeting the following criteria who are appropriate for azilsartan therapy in the opinion of the principal investigator or investigator

    • Patients aged ≥ 75 years at the time of informed consent: Sitting systolic blood pressure ≥ 150 mmHg or sitting diastolic blood pressure ≥ 90 mmHg
    • Patients aged < 75 years at the time of informed consent who concurrently have type 2 diabetes mellitus: Sitting systolic blood pressure ≥ 130 mmHg or sitting diastolic blood pressure ≥ 80 mmHg
    • Patients aged < 75 years at the time of informed consent who concurrently have chronic kidney disease (CKD) with proteinuria: Sitting systolic blood pressure ≥ 130 mmHg or sitting diastolic blood pressure ≥ 80 mmHg
    • Patients meeting none of the above: Sitting systolic blood pressure ≥ 140 mmHg or sitting diastolic blood pressure ≥ 90 mmHg
  2. Patients with stable angina with a coronary stenosis confirmed by coronary angiography who are planned to undergo percutaneous coronary intervention with stent placement (any type of stent)
  3. Patients with findings of integrated backscatter intravascular ultrasound (IB-IVUS) to be performed before the start of study treatment (Week 0) showing plaque at (≥ 5 mm in length) ≥ 5 mm proximal to the proximal end of the inserted stent in the coronary artery
  4. Patients with dyslipidemia meeting both of the following criteria:

    • Patients treated with one HMG-CoA reductase inhibitor with no change in the dosage for at least 12 weeks before informed consent
    • Patients with an LDL-C level of < 100 mg/dL as shown by a laboratory test performed within 4 weeks before informed consent
  5. Men or women aged 20 or older at the time of informed consent
  6. Patients capable of making outpatient study visits throughout the observation period
  7. Patients who, in the opinion of the principal investigator or investigator, are capable of understanding the contents of the clinical study and complying with the study requirements
  8. Patients capable of providing written consent in person before any study procedures

Exclusion Criteria:

  1. Patients with secondary hypertension or malignant hypertension
  2. Patients who took any renin-angiotensin system inhibitor within 12 weeks before informed consent
  3. Patients who previously underwent coronary artery bypass grafting
  4. Patients with type 1 diabetes mellitus
  5. Patients with insulin therapy
  6. Patients with an HbA1c level (National Glycohemoglobin Standardization Program [NGSP] value) of ≥ 7.0% as shown by a laboratory test performed within 4 weeks before informed consent
  7. Patients with the plaque unevaluable because of severe calcification of the coronary artery shown by IB-IVUS to be performed before the start of study treatment (Week 0)
  8. Patients with a change to their antidyslipidemic medication (including a change to the dosage) within 12 weeks before informed consent
  9. Patients with clinically evident renal disorder (defined as estimated glomerular filtration rate < 30 mL/min/1.73m2)
  10. Patients with severe liver disorder
  11. Patients with hyperkalemia (defined as serum potassium ≥ 5.5 mEq/L)
  12. Patients with a history of hypersensitivity or allergy to azilsartan
  13. Patients participating in any other clinical study
  14. Pregnant women, women with possible pregnancy, or breastfeeding women
  15. Other patients who are inappropriate for participation in this study in the opinion of the principal investigator or investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02400775


Locations
Japan
Tokushima, Japan
Sponsors and Collaborators
Takeda
Investigators
Study Director: General Manager Takeda

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02400775     History of Changes
Other Study ID Numbers: Azilsartan-4001
U1111-1167-9135 ( Registry Identifier: WHO )
JapicCTI-152834 ( Registry Identifier: JapicCTI )
First Posted: March 27, 2015    Key Record Dates
Last Update Posted: May 24, 2016
Last Verified: May 2016

Keywords provided by Takeda:
Pharmacotherapy

Additional relevant MeSH terms:
Angina Pectoris
Dyslipidemias
Angina, Stable
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms
Lipid Metabolism Disorders
Metabolic Diseases