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Slow patients enrollment
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The purpose of this study is to evaluate the effect of intensive blood pressure control compared to standard blood pressure control on progression of coronary atherosclerosis by intravascular ultrasound in hypertensive patients with coronary artery disease.
Antihypertensive therapy is reported to reduce cardiovascular events in patients with coronary artery disease. The goal of blood pressure in patients with coronary artery disease is recommended to control below 140/90mmHg. However, the effect of intensive blood pressure control compared to standard blood pressure control is still unknown. The purpose of this study is to evaluate the effect of intensive blood pressure control compared to standard blood pressure control on progression of coronary atherosclerosis by intravascular ultrasound in hypertensive patients with coronary atherosclerosis after 18 months. The goal of systolic blood pressure is under 120mmHg in intensive blood pressure control group and under 140mmHg in standard blood pressure control group. The design of this study is randomized control study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intensive blood pressure control | Active Comparator | systolic blood pressure less than 120 mmHg |
|
| standard blood pressure control | Active Comparator | systolic blood pressure less than 140 mmHg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| control systolic blood pressure less than 120 mmHg | Drug | use losartan to control blood pressure |
|
| Measure | Description | Time Frame |
|---|---|---|
| change of percent atheroma volume | change of percent atheroma volume measured by intravascular ultrasound | 1.5-year |
| Measure | Description | Time Frame |
|---|---|---|
| all cause death | Death from any cause | 1.5-year |
| cardiac death | Death from cardiac diseases | 1.5-year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Takeshi Kimura, MD, PhD | Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Cardiology, Kyoto University Hospital | Kyoto | Kyoto | 6066-8507 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36398903 | Derived | Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2022 Nov 18;11(11):CD010315. doi: 10.1002/14651858.CD010315.pub5. | |
| 32905623 | Derived | Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2020 Sep 9;9(9):CD010315. doi: 10.1002/14651858.CD010315.pub4. |
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| control systolic blood pressure less than 140 mmHg | Drug | use losartan to control blood pressure |
|
| cardiovascular death | Death from cardiovascular diseases | 1.5-year |
| myocardial infarction | myocardial infarction defined by ARC | 1.5-year |
| stroke | both ischemic and hemorrhagic strokes excluding transient ischemic attack | 1.5-year |
| target-lesion revascularization | target-lesion revascularization | 1.5-year |
| any coronary revascularization | any coronary revascularization | 1.5-year |
| hospitalization due to angina pectoris | hospitalization due to angina pectoris | 1.5-year |
| hospitalization due to heart failure | hospitalization due to heart failure | 1.5-year |
| change of total atheroma volume | change of total atheroma volume measured by intravascular ultrasond | 1.5-year |
| percent change of total atheroma volume | percent change of total atheroma volume measured by intravascular ultrasound | 1.5-year |
| change of atheroma volume at most severe 10mm lesion | change of atheroma volume at most severe 10mm lesion measured by intravascular ultrasound | 1.5-year |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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