ST-Segment Elevation Myocardial Infarction (STEMI)Phase 4AMPACTNCT07536802
Adenosine Pre-Medication in Primary Percutaneous Coronary Intervention
A Phase 4 study testing Adenosine pre-medication in people with ST-Segment Elevation Myocardial Infarction (STEMI) and No-Reflow Phenomenon, run by National Institute of Cardiovascular Diseases, Pakistan at 2 sites in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ST-Segment Elevation Myocardial Infarction (STEMI), No-Reflow Phenomenon, Coronary Slow Flow
- What is being tested?
- Adenosine pre-medication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,148 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Jun 2025to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with acute STEMI undergoing primary PCI
- Patients of either sex, ≥18 years of age.
Who cannot join
- STEMI patients with cardiogenic shock at presentation
- Patients with heart block
- Allergy to adenosine
- Patients refuse to give consent for participation
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan2 sites, 2 recruiting
- Recruiting
National Institute of Cardiovascular Diseases
Karachi, Sindh, 75510
Muhammad Nauman Khan, FCPS, +922199201271, nkhan116@yahoo.com
Khalid Naseeb, FCPS
- Recruiting
National Institute of Cardiovascular Diseases
Karachi, Sindh, 75510
Mushkbar Fatima, MBA, +922199201271, mushkbarfatima64@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- ST-Segment Elevation Myocardial Infarction (STEMI), No-Reflow Phenomenon, Coronary Slow Flow, Acute Myocardial Infarction
- Being tested
- Adenosine pre-medication, Standard care
- Keywords
- Adenonsine, Primary Percutaneous Coronary Intervention (Primary PCI), ST-Segment Elevation Myocardial Infarction (STEMI), No-Reflow Phenomenon, Coronary Slow Flow, Myocardial Reperfusion
- Medical subject headings
- ST Elevation Myocardial Infarction, No-Reflow Phenomenon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adenosine pre-medicationDrug
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).
Standard careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (Adenosine Pre-Medication + Standard Care) | Experimental | 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) Receives: Drug: Adenosine pre-medication; Other: Standard care |
| Control Group (Standard Care Alone) | Other | 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. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
Slow flow/no-reflow: will be categorized as final TIMI 0 to II flow
Measured: During Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start1 Jun 2025
- Primary completion30 May 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST-Segment Elevation Myocardial Infarction (STEMI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiovascular Diseases, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Muhammad Nauman Khan, National Institute of Cardiovascular Diseases, Pakistan
- Investigators
- Muhammad Nauman, FCPS, Principal investigator, National Institute of Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07536802
- Sponsor's protocol ID
- NICVDPakistan
- Acronym
- AMPACT
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adenosine Pre-Medication in Primary Percutaneous Coronary Intervention: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07536802
- Acronym / sponsor ID
- AMPACT / NICVDPakistan
- Conditions
- ST-Segment Elevation Myocardial Infarction (STEMI), No-Reflow Phenomenon, Coronary Slow Flow, Acute Myocardial Infarction
- Keywords
- Adenonsine, Primary Percutaneous Coronary Intervention (Primary PCI), ST-Segment Elevation Myocardial Infarction (STEMI), No-Reflow Phenomenon, Coronary Slow Flow, Myocardial Reperfusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,148 participants (estimated)
- Lead sponsor
- National Institute of Cardiovascular Diseases, PakistanUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (Adenosine Pre-Medication + Standard Care) | Experimental | Drug: Adenosine pre-medication, Other: Standard carePatients 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) |
| Control Group (Standard Care Alone) | Other | Other: Standard carePatients will undergo primary PCI with standard pharmacological therapy, without adenosine pre-medication. Purpose: Serve as comparator to evaluate the effect of adenosine pre-medication. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients with acute STEMI undergoing primary PCI
- Patients of either sex, ≥18 years of age.
Key exclusion criteria (4 listed)
- STEMI patients with cardiogenic shock at presentation
- Patients with heart block
- Allergy to adenosine
- Patients refuse to give consent for participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adenosine pre-medicationPatients 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). | Drug | Intervention Group (Adenosine Pre-Medication + Standard Care) |
| Standard carePatients 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), Intervention Group (Adenosine Pre-Medication + Standard Care) |
Primary outcome
Primary Outcome
Time frame: During Procedure
Slow flow/no-reflow: will be categorized as final TIMI 0 to II flow
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Muhammad Nauman, FCPS principal investigator
National Institute of Cardiovascular Diseases
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adenosine pre-medication in people with ST-Segment Elevation Myocardial Infarction (STEMI) and No-Reflow Phenomenon, run by National Institute of Cardiovascular Diseases, Pakistan at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Nauman Khan, FCPS (+923453549634, nkhan116@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: During Procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.