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| Name | Class |
|---|---|
| Kyungpook National University Hospital | OTHER |
| The Catholic University of Korea | OTHER |
| Cheil General Hospital and Women's Healthcare Center | OTHER |
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The purpose of this study is to evaluate the influence of aspirin on blood pressure in well-controlled hypertensive patients who receive low dose aspirin at different times of the day
Recent studies showed that low dose aspirin exerts a significant administration time-dependent effect on blood pressure in previously untreated hypertensive patients. However, this effect has not been confirmed in patients taking low-dose aspirin in combination with antihypertensive medications. A multi-center, double-blind randomized, cross-over, active-control, comparative clinical study will be conducted to evaluate the influence of aspirin on blood pressure in well-controlled hypertensive patients who receive low dose aspirin at different times of the day.
Approximately 192 patients will be enrolled over 4 months in 8 centers nationwide.
After placebo run-in period, all subjects will be randomized into one of the following 3 groups.
Group I & II will take low dose aspirin for treatment period (for first and second 12 weeks)on awakening or before bed time. Group III will take placebo for treatment period.
After first 12 weeks' treatment period, the subjects will be informed whether she/he belongs to Group III. This will be done without breaking the double blinding in the other 2 groups.
The primary objective will be the evaluation of the influence of aspirin on blood pressure in well-controlled hypertensive patients who receive low dose aspirin at different times of the day.
The secondary objectives will be 1) comparison of the administration time-dependent effects of low dose aspirin on blood pressure between dipper and non-dipper patients and 2) the evaluation of the effects of low dose aspirin in Korean hypertensive patients.
A sub-study will be conducted in 3 centers to evaluate the effect of aspirin on endothelial function in patients with well-controlled hypertension.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin enteric coated pellests 100mg | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| the changes in diastolic blood pressure |
| Measure | Description | Time Frame |
|---|---|---|
| the changes in systolic blood pressure | ||
| the trend in home blood pressure for medication | ||
| the comparison of the changes in systolic and diastolic pressure in dipper and non-dipper patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shung Chull Chae, Professor | Kyungpook National University Hospital | Study Chair |
| Dong Ju Choi, Professor | Seoul National University Bundang Hospital | Principal Investigator |
| Dong Su Kim, Professor | Inje University | Principal Investigator |
| Jeong Bae Park, Professor | Cheil General Hospital and Women's Healthcare Center | Principal Investigator |
| Nam Sik Chung, Professor | Severance Hospital | Principal Investigator |
| Sang Hong Baek, Professor | The Catholic University of Korea | Principal Investigator |
| Chang Wook Nam, Professor | Keimyung University Dongsan Medical Center | Principal Investigator |
| Young Jo Kim, Professor | Yeungnam University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook National University Hospital | Daegu | 700-721 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10912743 | Result | Avanzini F, Palumbo G, Alli C, Roncaglioni MC, Ronchi E, Cristofari M, Capra A, Rossi S, Nosotti L, Costantini C, Pietrofeso R. Effects of low-dose aspirin on clinic and ambulatory blood pressure in treated hypertensive patients. Collaborative Group of the Primary Prevention Project (PPP)--Hypertension study. Am J Hypertens. 2000 Jun;13(6 Pt 1):611-6. doi: 10.1016/s0895-7061(00)00231-4. | |
| 16034448 |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Inje University |
| OTHER |
| Keimyung University | OTHER |
| Seoul National University Bundang Hospital | OTHER |
| Severance Hospital | OTHER |
| Yeungnam University Hospital | OTHER |
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| Result |
| Magen E, Viskoper JR, Mishal J, Priluk R, London D, Yosefy C. Effects of low-dose aspirin on blood pressure and endothelial function of treated hypertensive hypercholesterolaemic subjects. J Hum Hypertens. 2005 Sep;19(9):667-73. doi: 10.1038/sj.jhh.1001910. |
| 9360028 | Result | Hermida RC, Fernandez JR, Ayala DE, Mojon A, Iglesias M. Influence of aspirin usage on blood pressure: dose and administration-time dependencies. Chronobiol Int. 1997 Nov;14(6):619-37. doi: 10.3109/07420529709001452. |
| 12623974 | Result | Hermida RC, Ayala DE, Iglesias M. Administration time-dependent influence of aspirin on blood pressure in pregnant women. Hypertension. 2003 Mar;41(3 Pt 2):651-6. doi: 10.1161/01.HYP.0000047876.63997.EE. Epub 2002 Dec 9. |
| Result | Hypertension 2005;46[part2]:1060-1068 |