Prevention of Coronary Microvascular Dysfunction Post-PCI by Intracoronary Nicardipine

NCT03184155 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: 17D.172
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center double blind, placebo controlled study of patients undergoing a cardiac catheterization where the need for a percutaneous coronary intervention (PCI) is anticipated or will be determined during the early diagnostic phase. The study will assess the use of intracoronary nicardipine vs. sterile saline injection in reducing the index measurement of microcirculatory resistance (IMR). Fifty consecutive patients presenting to the Thomas Jefferson University (TJUH) Cardiac Catheterization lab will be randomized in a 1:1 fashion to receive either intracoronary nicardipine or sterile saline injection prior to PCI. IMR values will be assessed pre and post procedure. Data on clinical outcomes and adverse events will be collected by phone at 30 days and 1 year following the procedure.

Conditions

Coronary Artery Disease

Keywords

Nicardipine; Percutaneous Coronary Intervention; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Change in Index of Microcirculatory Resistance (IMR)

  IMR is an intracoronary artery pressure measurement obtained during cardiac catheterization, and is a reliable indicator of microvascular dysfunction

  From the start of the PCI procedure to immediately following the PCI procedure

Secondary Outcomes (4)

• Post-Procedure myocardial Infarction (PMI)

  6-8 hours post procedure

• Post-Procedure myocardial Infarction (PMI)

  12-18 hours post procedure

• Major Adverse Cardiac Event

  30 Days following procedure

• Major Adverse Cardiac Event

  I year following procedure

Study Arms (2)

Intracoronary Nicardipine

EXPERIMENTAL

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.

Drug: Nicardipine

Sterile Saline

PLACEBO COMPARATOR

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.

Drug: Sterile Saline

Interventions

Nicardipine DRUG

200 mcg intracoronary nicardipine injection prior to PCI followed by an additional 2-4 doses of 100 mcg intracoronary nicardipine depending on complexity of PCI

Intracoronary Nicardipine

Sterile Saline DRUG

Bolus of intracoronary sterile saline injection prior to PCI followed by an additional 2-4 doses of sterile saline depending on complexity of PCI

Sterile Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consenting adults age \> 18 years
• Patients with stable coronary disease, stable angina, and/or objective evidence of myocardial ischemia OR
• Target vessel lesion with \> 50% stenosis treated by PCI

You may not qualify if:

• Patients presenting with ST elevation myocardial infarction
• Complete total occlusion of the vessel
• Unprotected left main disease
• Presentation with acute coronary syndrome and actively rising troponin
• Contraindication to adenosine (advanced heart blocks, bronchospasm, HSN to the drug)
• Known hypersensitivity to nicardipine
• Severe aortic stenosis
• Left Ventricular dysfunction with ejection fraction less than 30%
• Hemodynamically unstable defined as systolic blood pressure \< 90 mmHg and not responding to IV fluids
• Significant chronic renal insufficiency (Glomerular filtration rate \[GFR\] \<30)
• Unwilling or unable to provide informed consent

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Nicardipine

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Michael Savage, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized double blind, placebo controlled, study

Study Record Dates

• First Submitted: June 7, 2017
• First Posted: June 12, 2017
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)