Comparative Effectiveness of Dual Antihypertensive Regimens in Patients After Percutaneous Coronary Intervention (EDAM)
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.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Elizaveta Rogozhkina
- 電話番号：+7 (937) 104-73-31
- メール：lizarogozkina@gmail.com
研究場所
-
-
-
Moscow、ロシア
- 募集
- National Medical Research Center for therapy and preventive medicine
-
コンタクト：
- Oksana Drapkina
- 電話番号：+7 (495) 212-07-13
- メール：drapkina@bk.ru
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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.
|
|
アクティブコンパレータ：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in office systolic and diastolic blood pressure (mmHg)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Physical Limitation Score of the Seattle Angina Questionnaire (SAQ)
時間枠：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)
時間枠：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
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Oxana Drapkina、National Medical Research Center for therapy and preventive medicine
- スタディチェア：Olga Dzhioeva、National Medical Research Center for therapy and preventive medicine
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 04-03/26
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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