Comparative Effectiveness of Dual Antihypertensive Regimens in Patients After Percutaneous Coronary Intervention (EDAM)
27. juni 2026 oppdatert av: National Medical Research Center for Therapy and Preventive Medicine
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.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
207
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Elizaveta Rogozhkina
- Telefonnummer: +7 (937) 104-73-31
- E-post: lizarogozkina@gmail.com
Studiesteder
-
-
-
Moscow, Russland
- Rekruttering
- National Medical Research Center for therapy and preventive medicine
-
Ta kontakt med:
- Oksana Drapkina
- Telefonnummer: +7 (495) 212-07-13
- E-post: drapkina@bk.ru
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- Refusal or inability to provide informed consent
- Acute coronary syndrome
- Active malignancy
- Pulmonary embolism
- Chronic kidney disease stage 4-5
- Type 2 diabetes mellitus
- 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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: ARB + Thiazide Diuretic
Participants will receive dual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a thiazide diuretic after elective percutaneous coronary intervention.
|
Dual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a thiazide diuretic administered after elective percutaneous coronary intervention.
|
|
Aktiv komparator: ARB + Calcium Channel Blocker
Participants will receive dual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a dihydropyridine calcium channel blocker after elective percutaneous coronary intervention.
|
Dual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a dihydropyridine calcium channel blocker administered after elective percutaneous coronary intervention.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in office systolic and diastolic blood pressure (mmHg)
Tidsramme: 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
|
2 weeks, 4 weeks, and 12 weeks after hospital discharge
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Physical Limitation Score of the Seattle Angina Questionnaire (SAQ)
Tidsramme: 2 weeks, 4 weeks, and 12 weeks after hospital discharge
|
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
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2 weeks, 4 weeks, and 12 weeks after hospital discharge
|
|
Angina Frequency Score of the Seattle Angina Questionnaire (SAQ)
Tidsramme: 2 weeks, 4 weeks, and 12 weeks after hospital discharge
|
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
|
2 weeks, 4 weeks, and 12 weeks after hospital discharge
|
|
Participants requiring healthcare utilization during follow-up
Tidsramme: 2 weeks, 4 weeks, and 12 weeks after hospital discharge
|
Number of participants requiring at least one outpatient visit, emergency department visit, or hospitalization during follow-up
|
2 weeks, 4 weeks, and 12 weeks after hospital discharge
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Oxana Drapkina, National Medical Research Center for therapy and preventive medicine
- Studiestol: Olga Dzhioeva, National Medical Research Center for therapy and preventive medicine
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. april 2026
Primær fullføring (Antatt)
1. juli 2026
Studiet fullført (Antatt)
1. september 2026
Datoer for studieregistrering
Først innsendt
18. mai 2026
Først innsendt som oppfylte QC-kriteriene
27. juni 2026
Først lagt ut (Faktiske)
6. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 04-03/26
Plan for individuelle deltakerdata (IPD)
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