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Effects of Telmisartan on Ischemic Cardiovascular Events in High-risk Hypertensive Patients (KCPS)

Primary Purpose

Acute Myocardial Infarction, Angina Pectoris, Myocardial Ischemia

Status
Terminated
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Micardis (Telmisartan)
Blopress (Candesartan)
Sponsored by
Kyoto Prefectural University of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Myocardial Infarction focused on measuring angiotensin, receptor, vulnerable plaque, coronary artery

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The inclusion criteria are set by at least one of the three following risk factors:

  1. Coronary artery disease documented by at least one of the following:

    • Myocardial infarction at least 12 months before enrollment and not planned for percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
    • Angina pectoris or asymptomatic myocardial ischemia undergoing percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) at least 12 months before enrollment and not planned for further percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
  2. Peripheral arterial disease undergoing percutaneous transluminal angioplasty (PTA) or peripheral artery bypass grafting at least 6 months before enrollment
  3. Symptomatic cerebral infarction or cerebral hemorrhage at least 6 months before enrollment

Exclusion Criteria:

The exclusion criteria are set as follows:

  1. History of worsening of heart failure within the preceding 6 months
  2. Planned elective percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within the anteceding 3 months
  3. History of myocardial infarction, unstable angina pectoris, percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within the preceding 12 months
  4. History of percutaneous hind limb angioplasty (PTA) or bypass grafting within the preceding 6 months
  5. History of cerebral infarction, cerebral hemorrhage within the past 6 months
  6. Congenital heart disease
  7. Uncontrolled hypertension on treatment (eg, BP>180/110 mmHg)
  8. Pregnant women or women of childbearing potential
  9. Hepatic dysfunction (AST or ALT >100IU/L)
  10. Renal impairment (serum creatinine level >2.0 mg per 100 ml)
  11. Known hypersensitivity or intolerance to ARB

Sites / Locations

  • Shakaihoken Kobe Central Hospital
  • Akashi Municipal Hospital
  • Kouseikai Takeda Hospital
  • Aijyukai Dohjin Hospital
  • Kyoto Second Red Cross Hospital
  • Kyoto Prefectural University of Medicine
  • Social Insurance Kyoto Hospital
  • Kyoto Kojyo Hokenkai
  • Kyoto City Hospital
  • Kyoto First Red Cross Hospital
  • Aiseikai Yamashina Hospital
  • Tanabe Central Hospital
  • Rakusai Simizu Hospital
  • Uji Hospital
  • Kyoto Yawata Hospital
  • Seizinkai Simizu Hospital
  • Saiseikai Kyoto Hospital
  • Public Yamasiro Hospital
  • Gakkentoshi Hospital
  • Fukuchiyama City Hospital
  • Ayabe City Hospital
  • Maizuru Red Cross Hospital
  • National Hospital Organization Maizuru Medical Center
  • Maizuru Kyosai Hospital
  • Public Nantan Hospital
  • Kyoto Prefectural Yosanoumi Hospital
  • Kumihama Hospital
  • Sakurakai Takahashi Hospital
  • Yuuseikai Midorigaoka Hospital
  • Matsushita Memorial Hospital
  • Saiseikai Shiga Hospital
  • Omihachiman Community Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telmisartan

Candesartan

Arm Description

Treatment with Telmisartan

Treatment with Candesartan

Outcomes

Primary Outcome Measures

New or recurrent acute myocardial infarction and angina pectoris

Secondary Outcome Measures

All causes of mortality, cardiovascular death, new or recurrent stroke or peripheral artery diseases, new occurrence of diabetes mellitus

Full Information

First Posted
March 17, 2009
Last Updated
September 1, 2015
Sponsor
Kyoto Prefectural University of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00863980
Brief Title
Effects of Telmisartan on Ischemic Cardiovascular Events in High-risk Hypertensive Patients
Acronym
KCPS
Official Title
Effects of Telmisartan Compared With Candesartan on Ischemic Cardiovascular Events in High-risk Hypertensive Patients: a Multi-center, Prospective, Randomized, Open-labeled, Blinded Endpoints Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Why Stopped
Principle investigator resigned in 2013
Study Start Date
April 2009 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyoto Prefectural University of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is aimed to investigate whether treatment with Telmisartan is more effective than Candesartan in reducing the ischemic cardiovascular events in high-risk patients with cardiovascular disease.
Detailed Description
This study is aimed to investigate whether treatment with Telmisartan is more effective than Candesartan in reducing the ischemic cardiovascular events in high-risk patients with cardiovascular disease. Study design: PROBE(Prospective, Randomized, Open-labeled Blind Endpoints)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction, Angina Pectoris, Myocardial Ischemia, Acute Coronary Syndrome, Hypertension
Keywords
angiotensin, receptor, vulnerable plaque, coronary artery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telmisartan
Arm Type
Experimental
Arm Description
Treatment with Telmisartan
Arm Title
Candesartan
Arm Type
Active Comparator
Arm Description
Treatment with Candesartan
Intervention Type
Drug
Intervention Name(s)
Micardis (Telmisartan)
Other Intervention Name(s)
21600AMZ00541000, Micardis Tablets 40mg
Intervention Description
40-80 mg/day oral administration
Intervention Type
Drug
Intervention Name(s)
Blopress (Candesartan)
Other Intervention Name(s)
Blopless Tablets
Intervention Description
8-12 mg/day oral administration
Primary Outcome Measure Information:
Title
New or recurrent acute myocardial infarction and angina pectoris
Time Frame
3 years
Secondary Outcome Measure Information:
Title
All causes of mortality, cardiovascular death, new or recurrent stroke or peripheral artery diseases, new occurrence of diabetes mellitus
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The inclusion criteria are set by at least one of the three following risk factors: Coronary artery disease documented by at least one of the following: Myocardial infarction at least 12 months before enrollment and not planned for percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) Angina pectoris or asymptomatic myocardial ischemia undergoing percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) at least 12 months before enrollment and not planned for further percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) Peripheral arterial disease undergoing percutaneous transluminal angioplasty (PTA) or peripheral artery bypass grafting at least 6 months before enrollment Symptomatic cerebral infarction or cerebral hemorrhage at least 6 months before enrollment Exclusion Criteria: The exclusion criteria are set as follows: History of worsening of heart failure within the preceding 6 months Planned elective percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within the anteceding 3 months History of myocardial infarction, unstable angina pectoris, percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within the preceding 12 months History of percutaneous hind limb angioplasty (PTA) or bypass grafting within the preceding 6 months History of cerebral infarction, cerebral hemorrhage within the past 6 months Congenital heart disease Uncontrolled hypertension on treatment (eg, BP>180/110 mmHg) Pregnant women or women of childbearing potential Hepatic dysfunction (AST or ALT >100IU/L) Renal impairment (serum creatinine level >2.0 mg per 100 ml) Known hypersensitivity or intolerance to ARB
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hiroaki Matsubara, MD, PhD
Organizational Affiliation
Kyoto Prefectural University of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Shakaihoken Kobe Central Hospital
City
Kobe
ZIP/Postal Code
651-1145
Country
Japan
Facility Name
Akashi Municipal Hospital
City
Kobe
ZIP/Postal Code
673-8501
Country
Japan
Facility Name
Kouseikai Takeda Hospital
City
Kyoto
ZIP/Postal Code
600-8558
Country
Japan
Facility Name
Aijyukai Dohjin Hospital
City
Kyoto
ZIP/Postal Code
602-0917
Country
Japan
Facility Name
Kyoto Second Red Cross Hospital
City
Kyoto
ZIP/Postal Code
602-8026
Country
Japan
Facility Name
Kyoto Prefectural University of Medicine
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Social Insurance Kyoto Hospital
City
Kyoto
ZIP/Postal Code
603-8151
Country
Japan
Facility Name
Kyoto Kojyo Hokenkai
City
Kyoto
ZIP/Postal Code
604-8472
Country
Japan
Facility Name
Kyoto City Hospital
City
Kyoto
ZIP/Postal Code
604-8845
Country
Japan
Facility Name
Kyoto First Red Cross Hospital
City
Kyoto
ZIP/Postal Code
605-0981
Country
Japan
Facility Name
Aiseikai Yamashina Hospital
City
Kyoto
ZIP/Postal Code
607-8086
Country
Japan
Facility Name
Tanabe Central Hospital
City
Kyoto
ZIP/Postal Code
610-0334
Country
Japan
Facility Name
Rakusai Simizu Hospital
City
Kyoto
ZIP/Postal Code
610-1106
Country
Japan
Facility Name
Uji Hospital
City
Kyoto
ZIP/Postal Code
611-0011
Country
Japan
Facility Name
Kyoto Yawata Hospital
City
Kyoto
ZIP/Postal Code
614-8114
Country
Japan
Facility Name
Seizinkai Simizu Hospital
City
Kyoto
ZIP/Postal Code
615-8237
Country
Japan
Facility Name
Saiseikai Kyoto Hospital
City
Kyoto
ZIP/Postal Code
617-0814
Country
Japan
Facility Name
Public Yamasiro Hospital
City
Kyoto
ZIP/Postal Code
619-0214
Country
Japan
Facility Name
Gakkentoshi Hospital
City
Kyoto
ZIP/Postal Code
619-0238
Country
Japan
Facility Name
Fukuchiyama City Hospital
City
Kyoto
ZIP/Postal Code
620-8505
Country
Japan
Facility Name
Ayabe City Hospital
City
Kyoto
ZIP/Postal Code
623-0011
Country
Japan
Facility Name
Maizuru Red Cross Hospital
City
Kyoto
ZIP/Postal Code
624-0906
Country
Japan
Facility Name
National Hospital Organization Maizuru Medical Center
City
Kyoto
ZIP/Postal Code
625-8502
Country
Japan
Facility Name
Maizuru Kyosai Hospital
City
Kyoto
ZIP/Postal Code
625-8585
Country
Japan
Facility Name
Public Nantan Hospital
City
Kyoto
ZIP/Postal Code
629-0197
Country
Japan
Facility Name
Kyoto Prefectural Yosanoumi Hospital
City
Kyoto
ZIP/Postal Code
629-2261
Country
Japan
Facility Name
Kumihama Hospital
City
Kyoto
ZIP/Postal Code
629-3403
Country
Japan
Facility Name
Sakurakai Takahashi Hospital
City
Kyoto
ZIP/Postal Code
654-0026
Country
Japan
Facility Name
Yuuseikai Midorigaoka Hospital
City
Osaka
ZIP/Postal Code
569-1121
Country
Japan
Facility Name
Matsushita Memorial Hospital
City
Osaka
ZIP/Postal Code
570-8540
Country
Japan
Facility Name
Saiseikai Shiga Hospital
City
Shiga
ZIP/Postal Code
520-3046
Country
Japan
Facility Name
Omihachiman Community Medical Center
City
Shiga
ZIP/Postal Code
523-0892
Country
Japan

12. IPD Sharing Statement

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Effects of Telmisartan on Ischemic Cardiovascular Events in High-risk Hypertensive Patients

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