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Comparative Effectiveness of Dual Antihypertensive Regimens in Patients After Percutaneous Coronary Intervention (EDAM)

27. juni 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

207

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Rusland
      • Moscow, Rusland
        • Rekruttering
        • National Medical Research Center for Therapy and Preventive Medicine
        • Kontakt:
          • Oksana Drapkina
          • Telefonnummer: +7 (495) 212-07-13
          • E-mail: drapkina@bk.ru

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / 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.
Medicin: Losartan + Hydrochlorothiazide
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.
Medicin: Amlodipine + Azilsartan
Dual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a dihydropyridine calcium channel blocker administered after elective percutaneous coronary intervention.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Medical Research Center for Therapy and Preventive Medicine

Efterforskere

  • Ledende efterforsker: Oxana Drapkina, National Medical Research Center for Therapy and Preventive Medicine
  • Studiestol: Olga Dzhioeva, National Medical Research Center for Therapy and Preventive Medicine

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. april 2026

Primær færdiggørelse (Anslået)

1. juli 2026

Studieafslutning (Anslået)

1. september 2026

Datoer for studieregistrering

Først indsendt

18. maj 2026

Først indsendt, der opfyldte QC-kriterier

27. juni 2026

Først opslået (Faktiske)

6. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 04-03/26

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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Ingen

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