Effectiveness And Safety Of Dalteparin In Patients With Acute Coronary Syndromes Without ST Elevations In Clinical Practice

An observational study of Acute Coronary Syndrome, run by Pfizer at 24 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To collect data on safety and effectiveness of dalteparin in the management of non-ST segment elevated acute coronary syndromes in nursing home patients who will be treated conservatively (without percutaneous corornary intervention [PCI] or coronary artery bypass graft [CABG] within 48 hours). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Coronary Syndrome
What is being tested?: Dalteparin
How many people: 618 participants
Where: 24 sitesIndia
Study dates: May 2009to Sep 2010
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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: Patients management of non-ST segment elevated acute coronary syndromes in nursing home who will be treated conservatively (without percutaneous corornary intervention [PCI] or coronary artery bypass graft [CABG] within 48 hours).

Who may be able to join

Male or female patients of 18 years or more presenting with chest pain will be potentially eligible for inclusion in the study if they satisfy the criteria for unstable coronary artery disease per the investigator's routine practice and have received at least one injection of Fragmin (dalteparin sodium) as part of routine clinical practice and is expected to be treated conservatively (without PCI or CABG within 48 hours) during the index hospitalization.
Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Who cannot join

Patients who are contraindicated to receive this agent per the local approved prescribing information.

Trial locations and contacts

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

India24 sites

Pfizer Investigational Site
Ahmedabad, Gujarat, 380 051
Pfizer Investigational Site
Ambernath (E), Maharashtra, 421501
Pfizer Investigational Site
Bangalore, Karnataka, 562114
Pfizer Investigational Site
Bikaner, Rajasthan, 334003
Pfizer Investigational Site
Chennai, Tamil Nadu, 600 035
Pfizer Investigational Site
Hisar, Haryana, 125 001
Pfizer Investigational Site
Hisar, Haryana, 125005
Pfizer Investigational Site
Jaipur, Rajasthan, 302 012
Pfizer Investigational Site
Jaipur, Rajasthan, 302019
Pfizer Investigational Site
Kolkata, West Bengal, 700 019
Pfizer Investigational Site
Manglore, Karnataka, 575 018
Pfizer Investigational Site
Mysore, Karnataka, 570 020
Pfizer Investigational Site
Nagpur, Maharahtra, 440017
Pfizer Investigational Site
Nagpur, Maharashtra, 440 001
Pfizer Investigational Site
Nagpur, Maharashtra, 440 010
Pfizer Investigational Site
Nagpur, Maharashtra, 440012
Pfizer Investigational Site
Nagpur, Maharashtra, 440033
Pfizer Investigational Site
Nashik, Maharahtra, 3
Pfizer Investigational Site
Nashik, Maharashtra, 422 002
Pfizer Investigational Site
Nashik, Maharashtra, 422 009
Pfizer Investigational Site
Nashik Road, Maharashtra, 422 002
Pfizer Investigational Site
Nashik Road, Maharashtra, 422 101
Pfizer Investigational Site
Surat, Gujarat, 395004
Pfizer Investigational Site
Thane, Maharashtra

Other trials in India

About this study

Read the detailed description

Conditions: Acute Coronary Syndrome
Being tested: Dalteparin
Keywords: dalteparin non-ST segment elevated acute coronary syndromes
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.

DalteparinDrug
Patients prescribed dalteparin for non-ST segment elevated acute coronary syndromes in nursing home patients who will be treated conservatively (without corornary intervention [PCI] or coronary artery bypass graft [CABG] within 48 hours).

Study groups in NCT00922766
Study group	Role	What they receive
1.0		Not described Receives: Drug: Dalteparin

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Death or Myocardial Infarction (MI)
Measured: Baseline to 28 days after last dose of study drug
Number of Participants With Major Bleeding Events
Bleeding events were considered major if, accompanied by a decrease in hemoglobin of more than or equal to 2 grams/deciliter (g/dL) in connection with clinical symptoms; a transfusion was required; bleeding led to interruption of treatment or death; or intracranial bleeding.
Measured: Baseline to 28 days after last dose of study drug
Number of Participants With Minor Bleeding Events
Bleeding events like hematuria, wound hematoma or injection site hematoma which did not fulfill the criteria for a major bleeding episode were classified as minor bleeding.
Measured: Baseline to 28 days after last dose of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2009Sep 2010

First posted17 Jun 2009 (estimated)
Study startMay 2009
Primary completionSep 2010
Study completionSep 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
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: 618 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00922766
Sponsor's protocol ID: A6301088
Status last verified: Jan 2012
First submitted: 16 Jun 2009
Last updated: 23 Jan 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Coronary Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness And Safety Of Dalteparin In Patients With Acute Coronary Syndromes Without ST Elevations In Clinical Practice
ClinicalTrials.gov ID: NCT00922766
Acronym / sponsor ID: A6301088
Conditions: Acute Coronary Syndrome
Keywords: dalteparin non-ST segment elevated acute coronary syndromes
Study type: Observational
Recruitment status: Completed
Enrolment: 618 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: May 2009
Primary completion: Sep 2010 (actual)
Study completion: Sep 2010 (actual)
First posted: 17 Jun 2009 (estimated)
Results: Posted 11 Nov 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
1.0	–	Drug: Dalteparin

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients management of non-ST segment elevated acute coronary syndromes in nursing home who will be treated conservatively (without percutaneous corornary intervention [PCI] or coronary artery bypass graft [CABG] within 48 hours).

Key inclusion criteria (2 listed)

Male or female patients of 18 years or more presenting with chest pain will be potentially eligible for inclusion in the study if they satisfy the criteria for unstable coronary artery disease per the investigator's routine practice and have received at least one injection of Fragmin (dalteparin sodium) as part of routine clinical practice and is expected to be treated conservatively (without PCI or CABG within 48 hours) during the index hospitalization.
Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Key exclusion criteria (1 listed)

Patients who are contraindicated to receive this agent per the local approved prescribing information.

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
DalteparinPatients prescribed dalteparin for non-ST segment elevated acute coronary syndromes in nursing home patients who will be treated conservatively (without corornary intervention [PCI] or coronary artery bypass graft [CABG] within 48 hours).	Drug	1.0

Primary outcome

Number of Participants With Death or Myocardial Infarction (MI)
Time frame: Baseline to 28 days after last dose of study drug
Number of Participants With Major Bleeding Events
Time frame: Baseline to 28 days after last dose of study drug
Bleeding events were considered major if, accompanied by a decrease in hemoglobin of more than or equal to 2 grams/deciliter (g/dL) in connection with clinical symptoms; a transfusion was required; bleeding led to interruption of treatment or death; or intracranial bleeding.
Number of Participants With Minor Bleeding Events
Time frame: Baseline to 28 days after last dose of study drug
Bleeding events like hematuria, wound hematoma or injection site hematoma which did not fulfill the criteria for a major bleeding episode were classified as minor bleeding.

Results and safety

Results posted to the registry on 11 Nov 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dalteparin	617	610

Primary outcome: Number of Participants With Death or Myocardial Infarction (MI)

Time frame: Baseline to 28 days after last dose of study drug. Number. Unit: Participants

Measure	Dalteparin n = 617
Value	3

Population analysed: The full analysis set (FAS) included all enrolled participants who received at least 1 dose of the study medication.

Primary outcome: Number of Participants With Major Bleeding Events

Time frame: Baseline to 28 days after last dose of study drug. Number. Unit: Participants

Measure	Dalteparin n = 617
Value	0

Population analysed: FAS included all enrolled participants who received at least 1 dose of the study medication.

Primary outcome: Number of Participants With Minor Bleeding Events

Time frame: Baseline to 28 days after last dose of study drug. Number. Unit: Participants

Measure	Dalteparin n = 617
Value	1

Population analysed: FAS included all enrolled participants who received at least 1 dose of the study medication.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dalteparin	4 of 617 (0.6%)	23 of 617 (3.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Acute Coronary Syndrome

Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease

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. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

24 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Coronary Syndrome, run by Pfizer at 24 sites in India.

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 1 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: finished, as of the sponsor's last update on 23 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in India. 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?

Yes. Results are posted in the registry (first posted 11 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Death or Myocardial Infarction (MI) (time frame: Baseline to 28 days after last dose of study drug). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00922766.

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 23 Jan 2012; AzTrials last refreshed its copy on 8 Nov 2026.