Clinical trial NCT02901977: Doxazosin and Ramipril in Hypertension
Official title: On the Antithrombotic Effects of Doxazosin and Ramipril in Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Hypertension
Blood pressure
Hemostasis
Endothelial function
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized double-blind parallel group study in patients with mild-to-moderate hypertension to evaluate the effects beyond the blood pressure lowering effect of treatment for 12 weeks with ramipril or doxazosin on hemostatic mechanisms and on endothelial function.

Detailed description: This study aims to answer the following questions: 1) Does antihypertensive therapy with doxazosin exhibit antithrombotic effects in patients with essential hypertension? 2) Are the potential antithrombotic effects of doxazosin different to the effects of an ACE inhibitor? 3) Is there a relation between the antihypertensive effect and the antithrombotic effect of these antihypertensive agents?

The co-primary outcomes are changes in endothelial function assessed by flow mediated vasodilatation, and in haemostatic function measured by the generation of thrombin-antithrombin complex.

Eligibility criteria: Inclusion Criteria:

* Primary mild-to-moderate hypertension

Exclusion Criteria:

* Pregnancy and lactation
* Recent (6 months) malignant disease or ongoing treatment for malignancy
* No absolute indication or contraindication for any of the study drugs

Primary outcomes:
measure: Thrombin generation
timeFrame: 12 weeks
measure: Endothelial function
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet, Daprtment of Clinical Sciences, Danderyd Hospital, Cardiovascular Research Laboratory
Study officials:
affiliation: Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital
name: Thomas Kahan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jekell A, Kalani M, Kahan T. The interrelation of endothelial function and microvascular reactivity in different vascular beds, and risk assessment in hypertension: results from the Doxazosin-ramipril study. Heart Vessels. 2019 Mar;34(3):484-495. doi: 10.1007/s00380-018-1265-7. Epub 2018 Sep 22.
citation: Ekholm M, Jekell A, Wallen NH, Gigante B, Kahan T. Effects of Angiotensin-Converting Enzyme Inhibition and Alpha 1-Adrenergic Receptor Blockade on Inflammation and Hemostasis in Human Hypertension. J Cardiovasc Pharmacol. 2018 Apr;71(4):240-247. doi: 10.1097/FJC.0000000000000565.
citation: Jekell A, Kahan T. The usefulness of a single arm cuff oscillometric method (Arteriograph) to assess changes in central aortic blood pressure and arterial stiffness by antihypertensive treatment: results from the Doxazosin-Ramipril Study. Blood Press. 2018 Apr;27(2):88-98. doi: 10.1080/08037051.2017.1394791. Epub 2017 Oct 26.
citation: Jekell A, Kalani M, Kahan T. The effects of alpha 1-adrenoceptor blockade and angiotensin converting enzyme inhibition on central and brachial blood pressure and vascular reactivity: the doxazosin-ramipril study. Heart Vessels. 2017 Jun;32(6):674-684. doi: 10.1007/s00380-016-0924-9. Epub 2016 Nov 24.