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Calcium Channel Blocker

Nicardipine for Coronary Artery Disease

Phase < 1
Waitlist Available
Led By Michael Savage, MD
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with target vessel lesion with > 50% stenosis treated by PCI
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up i year following procedure
Awards & highlights

Study Summary

This trial will test whether nicardipine can reduce IMR, which may help improve clinical outcomes for people undergoing PCI.

Who is the study for?
Adults over 18 with coronary disease, stable angina, or signs of reduced blood flow to the heart who need a PCI and have at least 50% narrowing in a heart vessel. Not for those with severe heart attacks, very weak hearts (ejection fraction <30%), kidney issues (GFR <30), total vessel blockage, unstable blood pressure, certain main artery problems, recent acute coronary syndrome with rising troponin levels or allergies to nicardipine.Check my eligibility
What is being tested?
The trial is testing if injecting nicardipine directly into the heart's arteries before PCI can prevent small vessel damage better than saline solution. It's a blind test where neither patients nor doctors know who gets what treatment. They're comparing how well tiny vessels work before and after by measuring resistance.See study design
What are the potential side effects?
Possible side effects from intracoronary nicardipine may include low blood pressure, headache, swelling in the legs due to fluid buildup (edema), dizziness or lightheadedness when standing up too quickly (orthostatic hypotension), and possibly an allergic reaction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I had a procedure to open a narrowed artery in my heart.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~i year following procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and i year following procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Index of Microcirculatory Resistance (IMR)
Secondary outcome measures
Major Adverse Cardiac Event
Post-Procedure myocardial Infarction (PMI)

Side effects data

From 2022 Phase 2 trial • 120 Patients • NCT04116112
3%
Gastrointestinal hemorrhage associated with gastric ulcer
3%
New contralateral large vessel occlusion stroke
3%
Carotid artery re-occlusion
3%
Subarachnoid hemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lower SBP (<140mmHg) Target
Lower SBP (<160 mmHg) Target
Higher Systolic Blood Pressure (SBP) Target

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intracoronary NicardipineExperimental Treatment1 Intervention
200 mcg intracoronary injection of nicardipine prior to PCI, with potential for additional 100 mcg nicardipine before stent placement, balloon post-dilation, and before post-PCI IMR measurement.
Group II: Sterile SalinePlacebo Group1 Intervention
Injection of sterile saline prior to PCI, with potential for additional saline injections before stent placement, balloon post-dilation, and before post-PCI IMR measurement.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicardipine
2022
Completed Phase 4
~1940

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor
445 Previous Clinical Trials
145,664 Total Patients Enrolled
3 Trials studying Coronary Artery Disease
266 Patients Enrolled for Coronary Artery Disease
Michael Savage, MDPrincipal InvestigatorThomas Jefferson University

Media Library

Nicardipine (Calcium Channel Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT03184155 — Phase < 1
Coronary Artery Disease Research Study Groups: Intracoronary Nicardipine, Sterile Saline
Coronary Artery Disease Clinical Trial 2023: Nicardipine Highlights & Side Effects. Trial Name: NCT03184155 — Phase < 1
Nicardipine (Calcium Channel Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03184155 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what ways is Nicardipine generally employed?

"Nicardipine can provide relief from chronic stable angina pectoris, ischemia and brain hemorrhage."

Answered by AI

Are there any opportunities for patients to join this clinical experiment?

"As evidenced by clinicaltrials.gov, this trial has ceased to recruit additional patients since the last update on January 20th 2022. Nevertheless, there are still 578 studies that are currently enlisting volunteers at this time."

Answered by AI

How many participants are currently engaging in this medical experiment?

"This clinical trial has now closed and is no longer recruiting participants. First posted on December 1st 2022, the last edits were made on January 20th 2022. For those still interested in medical trials for coronary artery disease, 573 studies are currently open to enrolment; meanwhile, there are five active Nicardipine trials ready to accept patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Prevention of Coronary Microvascular Dysfunction Post-PCI by Intracoronary Nicardipine
2025. "Prevention of Coronary Microvascular Dysfunction Post-PCI by Intracoronary Nicardipine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03184155.
All > Coronary Artery Disease
~33 spots leftby Dec 2026
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