Intensive Blood Pressure and LDL Lowering in Diabetic Patients With Coronary Artery Disease

NCT01422421 | Completed Phase 4 DMC

• 1 other identifier: H21-rinsho shiken ippan-017
• Study Type: interventional
• Target: 798
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine whether intensive blood pressure and low density lipoprotein (LDL) cholesterol lowering could improve survival and cardiovascular outcome in Japanese diabetic patients with coronary artery disease and history of acute coronary syndrome.

Conditions

Type 2 Diabetes; Coronary Artery Disease; Hypertension; Dyslipidemia

Keywords

type 2 diabetes; coronary artery disease; hypertension; dyslipidemia

Outcome Measures

Primary Outcomes (2)

• composite endpoint

  composite endpoint consisting of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke and unstable angina requiring hospital administration

  3 years

• important secondary composite endpoint

  composite endpoint consisting of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, unstable angina requiring hospital administration, and admission for heart failure

  3 years

Secondary Outcomes (7)

• all-cause mortality

  3 years

• myocardial infarction

  3 years

• stroke

  3 years

• Cardiovascular death

  3 years

• end stage renal disease

  3 years

Study Arms (2)

intensive control

ACTIVE COMPARATOR

systolic blood pressure less than 120mmHg and LDL cholesterol within 70- 85mg/dl

Other: intensive control

standard control

ACTIVE COMPARATOR

systolic blood pressure less than 130mmHg and LDL cholesterol less than 100mg/dl

Other: standard control

Interventions

intensive control OTHER

use any medication to achieve systolic blood pressure less than 120mmHg and LDL cholesterol within 70-85mg/dl

intensive control

standard control OTHER

use any medication to achieve systolic blood pressure less than 130mmHg and LDL cholesterol less than 100mg/dl

standard control

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetic patients with coronary artery disease and history of acute coronary syndrome
• Patients whose blood pressure and LDL cholesterol levels are above values recommended by the current guideline

You may not qualify if:

• Patients who have active malignant tumor
• Patients who are on hemodialysis due to end stage kidney disease
• Patients whom statins are contraindicated
• Patients who had acute coronary syndrome or stroke within 3 months
• Patients who are pregnant or on breast feeding
• Patients whose physicians deem that attending this trial is contraindicated or inappropriate

Sponsors & Collaborators

• Takeshi Morimoto: lead
• University of the Ryukyus: collaborator

Study Sites (2)

University Hospital, University of the Ryukyus

Nishihara, Okinawa, 903-0215, Japan

Location

Saga University Hospital

Saga, 849-8501, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Coronary Artery Disease; Hypertension; Dyslipidemias

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Lipid Metabolism Disorders

Study Officials

• Shinichiro Ueda, MD, PhD

  Professor of Clinical Pharmacology and Therapeutics, University of the Ryukyus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 23, 2011
• First Posted: August 24, 2011
• Study Start: August 1, 2011
• Primary Completion: March 31, 2022
• Study Completion: December 31, 2023
• Last Updated: June 14, 2024

Record last verified: 2024-06

Locations

JP (2)