Acute Myocardial InfarctionKCPSNCT00863980
Effects of Telmisartan on Ischemic Cardiovascular Events in High-risk Hypertensive Patients
A study testing Micardis (Telmisartan) and Blopress (Candesartan) in people with Acute Myocardial Infarction and Angina Pectoris, run by Kyoto Prefectural University of Medicine at 32 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Acute Myocardial Infarction, Angina Pectoris, Myocardial Ischemia
- What is being tested?
- Micardis (Telmisartan) and Blopress (Candesartan)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 32 sitesJapan
- Study dates
- Apr 2009to Jul 2013
- 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
Japan32 sites
Shakaihoken Kobe Central Hospital
Kobe, Kobe, 651-1145
Akashi Municipal Hospital
Kobe, Kobe, 673-8501
Kouseikai Takeda Hospital
Kyoto, Kyoto, 600-8558
Aijyukai Dohjin Hospital
Kyoto, Kyoto, 602-0917
Kyoto Second Red Cross Hospital
Kyoto, Kyoto, 602-8026
Kyoto Prefectural University of Medicine
Kyoto, Kyoto, 602-8566
Social Insurance Kyoto Hospital
Kyoto, Kyoto, 603-8151
Kyoto Kojyo Hokenkai
Kyoto, Kyoto, 604-8472
Kyoto City Hospital
Kyoto, Kyoto, 604-8845
Kyoto First Red Cross Hospital
Kyoto, Kyoto, 605-0981
Aiseikai Yamashina Hospital
Kyoto, Kyoto, 607-8086
Tanabe Central Hospital
Kyoto, Kyoto, 610-0334
Rakusai Simizu Hospital
Kyoto, Kyoto, 610-1106
Uji Hospital
Kyoto, Kyoto, 611-0011
Kyoto Yawata Hospital
Kyoto, Kyoto, 614-8114
Seizinkai Simizu Hospital
Kyoto, Kyoto, 615-8237
Saiseikai Kyoto Hospital
Kyoto, Kyoto, 617-0814
Public Yamasiro Hospital
Kyoto, Kyoto, 619-0214
Gakkentoshi Hospital
Kyoto, Kyoto, 619-0238
Fukuchiyama City Hospital
Kyoto, Kyoto, 620-8505
Ayabe City Hospital
Kyoto, Kyoto, 623-0011
Maizuru Red Cross Hospital
Kyoto, Kyoto, 624-0906
National Hospital Organization Maizuru Medical Center
Kyoto, Kyoto, 625-8502
Maizuru Kyosai Hospital
Kyoto, Kyoto, 625-8585
Public Nantan Hospital
Kyoto, Kyoto, 629-0197
Kyoto Prefectural Yosanoumi Hospital
Kyoto, Kyoto, 629-2261
Kumihama Hospital
Kyoto, Kyoto, 629-3403
Sakurakai Takahashi Hospital
Kyoto, Kyoto, 654-0026
Yuuseikai Midorigaoka Hospital
Osaka, Osaka, 569-1121
Matsushita Memorial Hospital
Osaka, Osaka, 570-8540
Saiseikai Shiga Hospital
Shiga, Shiga, 520-3046
Omihachiman Community Medical Center
Shiga, Shiga, 523-0892
About this study
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
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.
Read the 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)
- Conditions
- Acute Myocardial Infarction, Angina Pectoris, Myocardial Ischemia, Acute Coronary Syndrome, Hypertension
- Being tested
- Micardis (Telmisartan), Blopress (Candesartan)
- Keywords
- angiotensin, receptor, vulnerable plaque, coronary artery
- Medical subject headings
- Angina Pectoris, Myocardial Ischemia, Acute Coronary Syndrome, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micardis (Telmisartan)Drug
Also called 21600AMZ00541000, Micardis Tablets 40mg
40-80 mg/day oral administration
Blopress (Candesartan)Drug
Also called Blopless Tablets
8-12 mg/day oral administration
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan | Experimental | Treatment with Telmisartan Receives: Drug: Micardis (Telmisartan) |
| Candesartan | Active comparator | Treatment with Candesartan Receives: Drug: Blopress (Candesartan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
New or recurrent acute myocardial infarction and angina pectoris
Measured: 3 years
Secondary outcomes (1)
All causes of mortality, cardiovascular death, new or recurrent stroke or peripheral artery diseases, new occurrence of diabetes mellitus
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionJul 2013
- Study completionJul 2013
Why it stopped: Principle investigator resigned in 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyoto Prefectural University of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hiroyuki Yamada, Kyoto Prefectural University of Medicine
- Investigators
- Hiroaki Matsubara, MD, PhD, Study chair, Kyoto Prefectural University of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00863980
- Sponsor's protocol ID
- C-486
- Other IDs
- UMIN000001762
- Acronym
- KCPS
- Status last verified
- Sep 2015
- First submitted
- 17 Mar 2009
- Last updated
- 3 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00863980
- Acronym / sponsor ID
- KCPS / C-486
- Conditions
- Acute Myocardial Infarction, Angina Pectoris, Myocardial Ischemia, Acute Coronary Syndrome, Hypertension
- Keywords
- angiotensin, receptor, vulnerable plaque, coronary artery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principle investigator resigned in 2013
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Kyoto Prefectural University of MedicineUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 18 Mar 2009 (estimated)
- 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.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telmisartan | Experimental | Drug: Micardis (Telmisartan)Treatment with Telmisartan |
| Candesartan | Active comparator | Drug: Blopress (Candesartan)Treatment with Candesartan |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Coronary artery disease documented by at least one of the following:
- 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
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| Micardis (Telmisartan)Also: 21600AMZ00541000, Micardis Tablets 40mg40-80 mg/day oral administration | Drug | Telmisartan |
| Blopress (Candesartan)Also: Blopless Tablets8-12 mg/day oral administration | Drug | Candesartan |
Primary outcome
New or recurrent acute myocardial infarction and angina pectoris
Time frame: 3 years
1 secondary outcome
All causes of mortality, cardiovascular death, new or recurrent stroke or peripheral artery diseases, new occurrence of diabetes mellitus
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Principle investigator resigned in 2013). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2015.
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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.
Hiroaki Matsubara, MD, PhD study chair
Kyoto Prefectural University of Medicine
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micardis (Telmisartan) and Blopress (Candesartan) in people with Acute Myocardial Infarction and Angina Pectoris, run by Kyoto Prefectural University of Medicine at 32 sites in Japan.
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 12 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: stopped early, as of the sponsor's last update on 3 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Japan. 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?
The study was stopped early (reason given: Principle investigator resigned in 2013). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New or recurrent acute myocardial infarction and angina pectoris (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Sep 2015.