HypertensionEDAMNCT07683585
Comparative Effectiveness of Dual Antihypertensive Regimens in Patients After Percutaneous Coronary Intervention
A study testing Losartan + Hydrochlorothiazide and Amlodipine + Azilsartan in people with Hypertension and Coronary Arterial Disease, run by National Medical Research Center for Therapy and Preventive Medicine at 1 site in Russia.
Trial summary
This prospective randomized open-label study aims to compare the effectiveness of two dual antihypertensive therapy regimens in patients with arterial hypertension and coronary artery disease after elective percutaneous coronary intervention (PCI) with coronary artery stenting. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Hypertension, Coronary Arterial Disease, Percutaneous Coronary Intervention
- What is being tested?
- Losartan + Hydrochlorothiazide and Amlodipine + Azilsartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteRussia
- Study dates
- 1 Apr 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50 to 70 years
- Arterial hypertension
- Coronary artery disease
- Hospitalization for elective percutaneous coronary intervention
- Coronary artery stenting during the current hospitalization
- Requirement for dual antihypertensive therapy
- Treatment with beta-blockers, lipid-lowering therapy, and antiplatelet therapy
- Ability and willingness to provide written informed consent
Who cannot join
- Refusal or inability to provide informed consent
- Acute coronary syndrome
- Active malignancy
- Pulmonary embolism
- Chronic kidney disease stage 4-5
- Type 2 diabetes mellitus
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- Contraindications or intolerance to study medications, including bilateral renal artery stenosis, hyperkalemia, hyperuricemia, or gout
- Women of reproductive age
- Permanent or persistent atrial fibrillation
- Planned staged coronary stenting
- Heart failure with reduced ejection fraction
- Any other condition that, in the investigator's opinion, may interfere with participation in the study or interpretation of study results
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
National Medical Research Center for Therapy and Preventive Medicine
Moscow
Oksana Drapkina, +7 (495) 212-07-13, drapkina@bk.ru
About this study
This prospective randomized open-label study aims to compare the effectiveness of two dual antihypertensive therapy regimens in patients with arterial hypertension and coronary artery disease after elective percutaneous coronary intervention (PCI) with coronary artery stenting.
Patients requiring dual antihypertensive therapy will be randomized to receive either an angiotensin receptor blocker (ARB) combined with a thiazide diuretic or an ARB combined with a dihydropyridine calcium channel blocker.
Read more
The study will evaluate blood pressure control, angina symptoms, quality of life, need for treatment intensification, and healthcare utilization during follow-up. Clinical status will be assessed at discharge and during telemedicine follow-up visits at 2 weeks, 4 weeks, and 12 weeks after hospital discharge.
The primary endpoint is the percentage reduction in systolic and diastolic blood pressure. Secondary endpoints include frequency of angina episodes, exercise limitations, patient satisfaction with treatment, and medical consultations during follow-up.
The study is investigator-initiated and plans to enroll at least 207 participants.
- Being tested
- Losartan + Hydrochlorothiazide, Amlodipine + Azilsartan
- Keywords
- Antihypertensive Therapy, Blood Pressure Control, Percuraneous Coronary Intervention, Angiotensin Receptor Blocker, Calcium Channel Blocker, Thiazide Diuretic
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Losartan + HydrochlorothiazideDrug
Dual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a thiazide diuretic administered after elective percutaneous coronary intervention.
Amlodipine + AzilsartanDrug
Dual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a dihydropyridine calcium channel blocker administered after elective percutaneous coronary intervention.
| Study group | Role | What they receive |
|---|---|---|
| ARB + Thiazide Diuretic | Active comparator | Participants will receive dual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a thiazide diuretic after elective percutaneous coronary intervention. Receives: Drug: Losartan + Hydrochlorothiazide |
| ARB + Calcium Channel Blocker | Active comparator | Participants will receive dual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a dihydropyridine calcium channel blocker after elective percutaneous coronary intervention. Receives: Drug: Amlodipine + Azilsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in office systolic and diastolic blood pressure (mmHg)
Assessment of changes in systolic and diastolic blood pressure values compared with baseline measurements after initiation of dual antihypertensive therapy following elective percutaneous coronary intervention
Measured: 2 weeks, 4 weeks, and 12 weeks after hospital discharge
Secondary outcomes (3)
Physical Limitation Score of the Seattle Angina Questionnaire (SAQ)
Assessment of exercise limitation using the Physical Limitation domain of the Seattle Angina Questionnaire (SAQ). Scores range from 0 to 100, with higher scores indicating less physical limitation and better functional status
Measured: 2 weeks, 4 weeks, and 12 weeks after hospital discharge
Angina Frequency Score of the Seattle Angina Questionnaire (SAQ)
Assessment of angina frequency using the Angina Frequency domain of the Seattle Angina Questionnaire (SAQ). Scores range from 0 to 100, with higher scores indicating fewer angina episodes and better angina control
Measured: 2 weeks, 4 weeks, and 12 weeks after hospital discharge
Participants requiring healthcare utilization during follow-up
Number of participants requiring at least one outpatient visit, emergency department visit, or hospitalization during follow-up
Measured: 2 weeks, 4 weeks, and 12 weeks after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Apr 2026
- Primary completionJul 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into two parallel treatment groups. One group will receive an angiotensin receptor blocker combined with a thiazide diuretic, and the other group will receive an angiotensin receptor blocker combined with a dihydropyridine calcium channel blocker. Outcomes will be assessed at 2, 4, and 12 weeks after hospital discharge.
- Masking
- None (open label)
- Enrolment
- 207 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Medical Research Center for Therapy and Preventive Medicine
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Olga Dzhioeva, Study chair, National Medical Research Center for Therapy and Preventive MedicineOxana Drapkina, Principal investigator, National Medical Research Center for Therapy and Preventive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683585
- Sponsor's protocol ID
- 04-03/26
- Acronym
- EDAM
- Status last verified
- Jun 2026
- First submitted
- 18 May 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Dual Antihypertensive Regimens in Patients After Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT07683585
- Acronym / sponsor ID
- EDAM / 04-03/26
- Keywords
- Antihypertensive Therapy, Blood Pressure Control, Percuraneous Coronary Intervention, Angiotensin Receptor Blocker, Calcium Channel Blocker, Thiazide Diuretic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 207 participants (estimated)
- Lead sponsor
- National Medical Research Center for Therapy and Preventive MedicineOther government
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 6 Jul 2026 (actual)
- 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 prospective randomized open-label study aims to compare the effectiveness of two dual antihypertensive therapy regimens in patients with arterial hypertension and coronary artery disease after elective percutaneous coronary intervention (PCI) with coronary artery stenting.
Patients requiring dual antihypertensive therapy will be randomized to receive either an angiotensin receptor blocker (ARB) combined with a thiazide diuretic or an ARB combined with a dihydropyridine calcium channel blocker.
The study will evaluate blood pressure control, angina symptoms, quality of life, need for treatment intensification, and healthcare utilization during follow-up. Clinical status will be assessed at discharge and during telemedicine follow-up visits at 2 weeks, 4 weeks, and 12 weeks after hospital discharge.
The primary endpoint is the percentage reduction in systolic and diastolic blood pressure. Secondary endpoints include frequency of angina episodes, exercise limitations, patient satisfaction with treatment, and medical consultations during follow-up.
The study is investigator-initiated and plans to enroll at least 207 participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized into two parallel treatment groups. One group will receive an angiotensin receptor blocker combined with a thiazide diuretic, and the other group will receive an angiotensin receptor blocker combined with a dihydropyridine calcium channel blocker. Outcomes will be assessed at 2, 4, and 12 weeks after hospital discharge.
| Arm | Type | Receives |
|---|---|---|
| ARB + Thiazide Diuretic | Active comparator | Drug: Losartan + HydrochlorothiazideParticipants will receive dual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a thiazide diuretic after elective percutaneous coronary intervention. |
| ARB + Calcium Channel Blocker | Active comparator | Drug: Amlodipine + AzilsartanParticipants will receive dual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a dihydropyridine calcium channel blocker after elective percutaneous coronary intervention. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 50 to 70 years
- Arterial hypertension
- Coronary artery disease
- Hospitalization for elective percutaneous coronary intervention
- Coronary artery stenting during the current hospitalization
Key exclusion criteria (12 listed)
- Refusal or inability to provide informed consent
- Acute coronary syndrome
- Active malignancy
- Pulmonary embolism
- Chronic kidney disease stage 4-5
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 |
|---|---|---|
| Losartan + HydrochlorothiazideDual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a thiazide diuretic administered after elective percutaneous coronary intervention. | Drug | ARB + Thiazide Diuretic |
| Amlodipine + AzilsartanDual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a dihydropyridine calcium channel blocker administered after elective percutaneous coronary intervention. | Drug | ARB + Calcium Channel Blocker |
Primary outcome
Change in office systolic and diastolic blood pressure (mmHg)
Time frame: 2 weeks, 4 weeks, and 12 weeks after hospital discharge
Assessment of changes in systolic and diastolic blood pressure values compared with baseline measurements after initiation of dual antihypertensive therapy following elective percutaneous coronary intervention
3 secondary outcomes
Physical Limitation Score of the Seattle Angina Questionnaire (SAQ)
Time frame: 2 weeks, 4 weeks, and 12 weeks after hospital discharge
Angina Frequency Score of the Seattle Angina Questionnaire (SAQ)
Time frame: 2 weeks, 4 weeks, and 12 weeks after hospital discharge
Participants requiring healthcare utilization during follow-up
Time frame: 2 weeks, 4 weeks, and 12 weeks after hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Olga Dzhioeva study chair
National Medical Research Center for Therapy and Preventive Medicine
Oxana Drapkina principal investigator
National Medical Research Center for Therapy and Preventive Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Losartan + Hydrochlorothiazide and Amlodipine + Azilsartan in people with Hypertension and Coronary Arterial Disease, run by National Medical Research Center for Therapy and Preventive Medicine at 1 site in Russia.
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 8 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: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizaveta Rogozhkina (+7 (937) 104-73-31, lizarogozkina@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in office systolic and diastolic blood pressure (mmHg) (time frame: 2 weeks, 4 weeks, and 12 weeks after hospital discharge). 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 6 Jul 2026.