Adenosine Pre-Medication in Primary Percutaneous Coronary Intervention (AMPACT)

April 17, 2026 updated by: Dr. Muhammad Nauman Khan, National Institute of Cardiovascular Diseases, Pakistan

Adenosine Pre-Medication in Primary Percutaneous Coronary Intervention: A Randomized Control Trial

Primary objective of the study is to evaluate the impact of adenosine pre-medication on incidence of slow flow/no-reflow after primary percutaneous coronary intervention.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background:

Primary percutaneous coronary intervention (PCI) is the preferred reperfusion strategy for ST-segment elevation myocardial infarction (STEMI); however, optimal myocardial perfusion is not achieved in all patients due to the slow flow/no-reflow phenomenon. This condition, defined as inadequate myocardial perfusion despite patent epicardial arteries, is associated with worse clinical outcomes. Adenosine, owing to its vasodilatory, anti-inflammatory, and antiplatelet properties, may improve microvascular perfusion. While its use during PCI is established, its prophylactic role prior to PCI remains unclear.

Study Design:

This is a multicenter, single-blinded, randomized controlled trial conducted at NICVD Karachi and its satellite centers (Liyari and Larkana) over 12 months. A total of 1,148 STEMI patients undergoing primary PCI will be randomized in a 1:1 ratio using block randomization.

Intervention:

Intervention Group: Intracoronary adenosine pre-medication (2 mg for left coronary artery, 1 mg for right coronary artery, diluted in 20 mL normal saline) plus standard care.

Control Group: Standard pharmacological management alone.

Participants:

Adults (≥18 years) with STEMI undergoing primary PCI. Key exclusions include cardiogenic shock, heart block, adenosine allergy, and refusal to consent.

Outcomes:

Primary Outcome: Incidence of slow flow/no-reflow (TIMI flow grade 0-II). Secondary Outcome: Myocardial Blush Grade (0-III).

Safety:

Potential adverse effects such as transient bradycardia or heart block will be managed per institutional protocols.

Data and Analysis:

Baseline, procedural, and outcome data will be collected. Statistical analysis will be performed using SPSS, with appropriate tests applied for continuous and categorical variables. A p-value ≤0.05 will be considered significant.

Study Type

Interventional

Enrollment (Estimated)

1148

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75510
        • Recruiting
        • National Institute of Cardiovascular Diseases
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All patients with acute STEMI undergoing primary PCI
  • Patients of either sex, ≥18 years of age.

Exclusion Criteria:

  • STEMI patients with cardiogenic shock at presentation
  • Patients with heart block
  • Allergy to adenosine
  • Patients refuse to give consent for participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group (Adenosine Pre-Medication + Standard Care)

Patients will receive intracoronary adenosine prior to primary PCI:

Dose: 2 mg for left coronary artery, 1 mg for right coronary artery Dilution: 20 mL normal saline Route: Intracoronary (proximal via guide or distal via device) Purpose: To reduce incidence of slow flow/no-reflow and improve myocardial perfusion.

Other Names: Adenocard (if needed for registry consistency)
Drug: Adenosine pre-medication

Patients will receive intracoronary adenosine before primary PCI in addition to standard pharmacological therapy:

Dose: 2 mg for left coronary artery, 1 mg for right coronary artery Dilution: 20 mL normal saline Route: Intracoronary (proximal via guide catheter or distal via delivery device) Timing: Administered immediately prior to PCI Purpose: To evaluate whether adenosine pre-medication reduces the incidence of slow flow/no-reflow and improves myocardial perfusion outcomes (TIMI flow grade and Myocardial Blush Grade).

Other: Standard care

Patients will receive standard pharmacological management during primary PCI without adenosine pre-medication.

Purpose: Serves as the control to assess the effect of adenosine on slow flow/no-reflow and myocardial perfusion.
Other: Control Group (Standard Care Alone)

Patients will undergo primary PCI with standard pharmacological therapy, without adenosine pre-medication.

Purpose: Serve as comparator to evaluate the effect of adenosine pre-medication.
Other: Standard care

Patients will receive standard pharmacological management during primary PCI without adenosine pre-medication.

Purpose: Serves as the control to assess the effect of adenosine on slow flow/no-reflow and myocardial perfusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Outcome
Time Frame: During Procedure
Slow flow/no-reflow: will be categorized as final TIMI 0 to II flow
During Procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Cardiovascular Diseases, Pakistan

Investigators

  • Principal Investigator: Muhammad Nauman, FCPS, National Institute of Cardiovascular Diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 10, 2026

First Submitted That Met QC Criteria

April 10, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NICVDPakistan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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