Major BleedingDATESNCT07039149
Pretreatment of Acute Coronary Syndrome With Dual Antiplatelet Agents
An observational study of Major Bleeding and Major Adverse Cardiovascular and Cerebrovascular Events (MACCE), run by Jordan Collaborating Cardiology Group at 2 sites in Jordan.
Trial summary
This is a chart review of data on use of antiplatelet (AP) medications for acute coronary syndrome in the ER. Guidelines recommend giving aspirin in the ER and a second AP agent in the cath lab. What is the outcome when the 2 agents are given n the ER? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Bleeding, Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
- How many people
- 200 participants
- Where
- 2 sitesJordan
- Study dates
- 1 Aug 2025to 1 Nov 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will enroll adult patients, men and women, who present to the emergency department (ED) with acute coronary syndrome (ST segment elevation myocardial infarction, non ST segment elevation myocardial infarction, and unstable angina) and who are prescribed aspirin in the ED and a second oral antiplatelet medication either in the ED (not according to recent guidelines) or upon identification of the coronary anatomy in the cath lab (based on recent guidelines). Incidence of bleeding and other cardiovascular events in these patients based in timing of administering the antiplatelet therapy.
Who may be able to join
- Adult patients
- Presenting with acute coronary syndrome (ST segment elevation myocardial infarction, non ST segment elevation myocardial infarction, and unstable angina).
- Antiplatelet medication (s) prescribed during index admission to hospital.
- Willingness of the patient to be called for follow up up to 1 year after index hospitalization.
Who cannot join
- Non cardiac chest pain.
- No administration of antiplatelet agents during hospitalization.
- Refusal of contact for follow up.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jordan2 sites, 2 recruiting
- Recruiting
Jordan University Hospital
Amman, 11180
Ayman Hammoudeh, MD, FACC, 065001000, hammoudeh_ayman@yahoo.com
- Not yet recruiting
Istishari Hospital
Amman, 11184
Ayman Hammoudeh, MD, FACC, 065001000, hammoudeh_ayman@yahoo.com
Laith Habahbeh, MD, 065001000, researchculture2020@gmail.com
About this study
Official title: Dual Antiplatelet Agents Therapy in the Emergency Department for Acute Coronary Syndrome (The DATES Study).
This is a chart review of data on use of antiplatelet (AP) medications for acute coronary syndrome in the ER. Guidelines recommend giving aspirin in the ER and a second AP agent in the cath lab. What is the outcome when the 2 agents are given n the ER?
Read the detailed description
Dual antiplatelet therapy (DAPT) is a standard treatment in ST-elevation myocardial infarction (STEMI) and non-ST-segment-elevation acute coronary syndrome (NSTEACS) . However, the timing of initiation of DAPT in the Emergency Department (ED) has been defined by recent western guidelines (i.e., aspirin in the ER and and a second AP agent when the coronary anatomy has been denied in the cath lab. This strategy aims at decreasing the incidence of bleeding events. However, patients with ACS in the Middle East are younger than those in the West and have lower bleeding risk. The purpose of this study is to evaluate the incidence of major bleeding in patients who received DAPT in the ED according to the discretion of the treating physician.
- Keywords
- Dual antiplatelet therapy, Pretreatment with DAPT, Acute coronary syndrome
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients admitted for acute coronary syndrome via the ED | Patients with ACS presenting to the ED with a planned coronary angiography for possible coronary revascularization who get aspirin in the ED will be evaluated for bleeding and major cardiovascular events when they receive a second antiplatelet agent in the ED compared with in the cath lab. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major bleeding event
Major bleeding event is defined as any of the following: 1. bleeding causing hemodynamic compromise, 2. bleeding necessitating blood transfusion, or 3. bleeding in a closed space (intracerebral intraspinal and intraocular).
Measured: From enrollment to the end of the study at 1 year.
Secondary outcomes (1)
Major adverse cardiovascular and cerebral events
Occurrence of any of the followings: 1. Cardiovascular death (death due to documented cardiovascular event: fatal myocardial infarction, or fatal stroke), 2. Non fatal myocardial infarction (two of three criteria: ischemic chest pain, electrocardiographic changes [ST segment deviation and T wave inversion] and elevated cardiac enzymes), 2. Definite stent thrombosis (demonstrating a thrombus in the stent on coronary angiography), 3. Non fatal stroke (new neurological deficit compatible with cerebral ischemia, brain imaging by computed tomography or magnetic resonance showing typical stroke, ischemic or hemorrhagic), 4. Coronary revascularization by percutaneous intervention or coronary bypass surgery.
Measured: from enrollment to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start1 Aug 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major BleedingStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Jordan Collaborating Cardiology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman J Hammoudeh, MD, FACC, Jordan Collaborating Cardiology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039149
- Sponsor's protocol ID
- DATES.2.25/irbIH1725
- Acronym
- DATES
- Status last verified
- Nov 2025
- First submitted
- 18 Jun 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Antiplatelet Agents Therapy in the Emergency Department for Acute Coronary Syndrome (The DATES Study).
- ClinicalTrials.gov ID
- NCT07039149
- Acronym / sponsor ID
- DATES / DATES.2.25/irbIH1725
- Keywords
- Dual antiplatelet therapy, Pretreatment with DAPT, Acute coronary syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jordan Collaborating Cardiology GroupUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 26 Jun 2025 (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.
This is a chart review of data on use of antiplatelet (AP) medications for acute coronary syndrome in the ER. Guidelines recommend giving aspirin in the ER and a second AP agent in the cath lab. What is the outcome when the 2 agents are given n the ER?
Detailed description
Dual antiplatelet therapy (DAPT) is a standard treatment in ST-elevation myocardial infarction (STEMI) and non-ST-segment-elevation acute coronary syndrome (NSTEACS) . However, the timing of initiation of DAPT in the Emergency Department (ED) has been defined by recent western guidelines (i.e., aspirin in the ER and and a second AP agent when the coronary anatomy has been denied in the cath lab. This strategy aims at decreasing the incidence of bleeding events. However, patients with ACS in the Middle East are younger than those in the West and have lower bleeding risk. The purpose of this study is to evaluate the incidence of major bleeding in patients who received DAPT in the ED according to the discretion of the treating physician.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients admitted for acute coronary syndrome via the ED | – | –Patients with ACS presenting to the ED with a planned coronary angiography for possible coronary revascularization who get aspirin in the ED will be evaluated for bleeding and major cardiovascular events when they receive a second antiplatelet agent in the ED compared with in the cath lab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll adult patients, men and women, who present to the emergency department (ED) with acute coronary syndrome (ST segment elevation myocardial infarction, non ST segment elevation myocardial infarction, and unstable angina) and who are prescribed aspirin in the ED and a second oral antiplatelet medication either in the ED (not according to recent guidelines) or upon identification of the coronary anatomy in the cath lab (based on recent guidelines). Incidence of bleeding and other cardiovascular events in these patients based in timing of administering the antiplatelet therapy.
Key inclusion criteria (4 listed)
- Adult patients
- Presenting with acute coronary syndrome (ST segment elevation myocardial infarction, non ST segment elevation myocardial infarction, and unstable angina).
- Antiplatelet medication (s) prescribed during index admission to hospital.
- Willingness of the patient to be called for follow up up to 1 year after index hospitalization.
Key exclusion criteria (3 listed)
- Non cardiac chest pain.
- No administration of antiplatelet agents during hospitalization.
- Refusal of contact for follow up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major bleeding event
Time frame: From enrollment to the end of the study at 1 year.
Major bleeding event is defined as any of the following: 1. bleeding causing hemodynamic compromise, 2. bleeding necessitating blood transfusion, or 3. bleeding in a closed space (intracerebral intraspinal and intraocular).
1 secondary outcome
Major adverse cardiovascular and cerebral events
Time frame: from enrollment to 1 year
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 28 Nov 2025.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Bleeding and Major Adverse Cardiovascular and Cerebrovascular Events (MACCE), run by Jordan Collaborating Cardiology Group at 2 sites in Jordan.
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 4 inclusion and 3 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 28 Nov 2025. 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 Jordan. 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.
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 Ayman Hammoudeh, MD, FACC (+96265001000, hammoudeh_ayman@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major bleeding event (time frame: From enrollment to the end of the study at 1 year.). 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 28 Nov 2025.