---
title: Safety and Efficacy of Empagliflozin for Patients With Diabetes Mellitus and Planned Percutaneous Coronary Interventions
nct_id: NCT04497792
overall_status: COMPLETED
phase: PHASE4
sponsor: Research Institute for Complex Problems of Cardiovascular Diseases, Russia
study_type: INTERVENTIONAL
primary_condition: Coronary Artery Disease
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04497792.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04497792"
ct_last_update_post_date: 2021-09-22
last_seen_at: "2026-05-12T06:33:09.284Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Safety and Efficacy of Empagliflozin for Patients With Diabetes Mellitus and Planned Percutaneous Coronary Interventions

**Official Title:** A Long-term, Randomized Study to Evaluate the Effects of Empagliflozin in Combination With Standard Hypoglycemic Therapy on Early and Long-term Results of Planned Percutaneous Coronary Interventions in Patients With Type 2 Diabetes.

**NCT ID:** [NCT04497792](https://clinicaltrials.gov/study/NCT04497792)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 40
- **Lead Sponsor:** Research Institute for Complex Problems of Cardiovascular Diseases, Russia
- **Conditions:** Coronary Artery Disease, Diabetes Mellitus, Percutaneous Coronary Intervention
- **Start Date:** 2016-11
- **Completion Date:** 2019-11
- **CT.gov Last Update:** 2021-09-22

## Brief Summary

Aim: To study the effectiveness and safety of empagliflozin as a preoperative preparation tool, as well as to improve the long-term prognosis of planned percutaneous coronary interventions in patients with type 2 diabetes

## Detailed Description

Patients with type 2 diabetes will be randomized into 2 groups using the envelope method. One group will receive empagliflozin 10 mg 1 month before planned percutaneous coronary interventions and for 12 months thereafter in addition to previously taken hypoglycemic therapy. Patients of the second group will continue to take previously prescribed hypoglycemic therapy.

Thus, the safety and effectiveness of empagliflozin for preoperative preparation of patients with type 2 diabetes before planned percutaneous coronary interventions will be evaluated, as well as the impact on the immediate and long-term outcomes of percutaneous coronary interventions in comparison with patients on standard hypoglycemic therapy

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* signed inform concent
* stable coronary artery disease
* planned percutaneous coronary intervention
* diabetes mellitus

Exclusion Criteria:

* previously performed coronary revascularization
* glomerular filtration rate less than 45 ml/min
* intolerance to empagliflozin
* serum potassium more than 5/5 mmol/l
* heart failure (NYHA III-IV)
* congenital heart disease
* acute coronary syndrome less than 3 months before enrollment
```

## Arms

- **Treatment group** (EXPERIMENTAL) — The treatment group are patients with stable coronary artery disease before planned percutaneous coronary intervention. All of them will receive empagliflozin additionally to previously taken hypoglycemic treatment.
- **Control group** (OTHER) — patients continue previously prescribed medication intake

## Interventions

- **Empagliflozin 10Mg Tab** (DRUG) — Patients from treatment group received empagliflozin 10 mg daily additionally to previously prescribed diabetes medication
- **hypoglycemic therapy** (DRUG) — hypoglycemic therapy.

## Primary Outcomes

- **glomerular filtration rate(GFR)** _(time frame: baseline-24 weeks)_ — The glomerular filtration rate(GFR) will be measured at each visit. GFR more than 60 will be recognized as normal.
- **HbA1C level** _(time frame: baseline-24 weeks)_ — The HbA1C will be measured (in %) at each visit. HbA1C less than 6.1% will be recognized as normal.

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04497792.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04497792*  
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