Angina, UnstablePhase 4NCT00435487

Dalteparin Versus Unfractionated Heparin In Patients With Acute Coronary Syndrome

A Phase 4 study testing Dalteparin ( Fragmin) and Unfractionated heparin in people with Angina, Unstable and Myocardial Infarction, run by Pfizer at 8 sites in India.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

To compare efficacy and safety of dalteparin compared to unfractionated heparin in patients of non ST elevation acute coronary syndromes who are planned to undergo coronary interventions (angioplasty or bypass surgery) Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Angina, Unstable, Myocardial Infarction
What is being tested?: Dalteparin ( Fragmin) and Unfractionated heparin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 173 participants
Where: 8 sitesIndia
Study dates: Jun 2007to Dec 2008
Phase: Phase 4
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

Who may be able to join

Patients more than 18 years
Ischemic pain of more than 10 minutes within 24 hours before enrollment
At least two of the following three risk factors : Age more than 60 years ( or more than 50 in case of diabetics), Raised cardiac enzyme levels, abnormal ECG findings

Who cannot join

Contraindications to use of anticoagulants
Active bleeding or abnormal coagulation tests
Ischemic stroke within last 6 months or hemorrhagic stroke
Lumbar or spinal puncture within last 48 hours
S creatinine levels more than 2

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

India8 sites

Pfizer Investigational Site
Coimbatore, Tamil Nadu, 641 014
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, 500 001
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, 500 034
Pfizer Investigational Site
Karnataka, 560 034
Pfizer Investigational Site
Ludhiana, Punjab, 141 001
Pfizer Investigational Site
Nagpur, Maharashtra, 440 012
Pfizer Investigational Site
Pune, Maharashtra, 411 001
Pfizer Investigational Site
Pune, Maharashtra, 411 004

Other trials in India

About this study

Official title: Prospective Randomized Phase IV Open Label Comparative Study Of Dalteparin vs Unfractionated Heparin In High Risk Patients Of Non-ST Elevation Acute Coronary Syndromes Intended For Early Invasive Strategy

Read the detailed description

The study was prematurely discontinued on November 30, 2008 due to delay in meeting pre-defined protocol recruitment milestones. There were no safety concerns regarding the study in the decision to terminate the trial.

Conditions: Angina, Unstable, Myocardial Infarction
Being tested: Dalteparin ( Fragmin), Unfractionated heparin
Keywords: Non-ST Elevation Acute Coronary Syndromes coronary interventions
Medical subject headings: Angina, Unstable, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dalteparin ( Fragmin)Drug
Dalteparin will be administered at a dose of 120 IU/kg (international units per kilogram) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours.
Unfractionated heparinDrug
Unfractionated heparin will be given intravenously according to a weight-adjusted nomogram (bolus of 60 U/kg [units per kilogram] and initial infusion of 12 U/kg/h [units per kilogram per hour]).

Study groups in NCT00435487
Study group	Role	What they receive
A	Experimental	Not described Receives: Drug: Dalteparin ( Fragmin)
B	Active comparator	Not described Receives: Drug: Unfractionated heparin

What is being measured

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

Number of Subjects With Death or Non-fatal Myocardial Infarction Through and Up to Day 30
Death or non-fatal myocardial infarction (MI) after receiving 48 hours of study medication (event date - first dose date) on or before day 30 from baseline. Death: fatal event resulting from any cause. New MI: electrocardiographic (ECG) and or biomarker criteria of myocardial necrosis. Biochemical markers: creatine phosphokinase - myocardial band (CPK-MB) levels and the qualitative troponin-T test.
Measured: Baseline to Day 30

Secondary outcomes (5)

Number of Subjects With Stroke
Stroke: a sudden, focal neurologic deficit that is not reversible within 24 hours and is not the result of any readily identifiable cause (e.g., tumor or trauma).
Measured: End of hospitalization, Day 30
Number of Subjects With Recurrent Angina With or Without Need for Hospitalization and or Revascularization
Recurrent angina: angina at rest lasting at least five minutes that was associated with a new ST-segment shift (elevation or depression) of more than 0.1 millivolt (mV), or with T-wave inversions, in two contiguous electrocardiographic leads; angina without electrocardiographic changes that prompted a decision to perform a revascularization procedure; or angina after hospital discharge that resulted in rehospitalization.
Measured: End of hospitalization, Day 30
Number of Subjects With Death or Non-fatal Myocardial Infarction (MI), Computed Separately, at End of Hospitalization and 30 Days
Death or non-fatal myocardial infarction (MI) after receiving 48 hours of study medication (event date - first dose date) at end of hospitalization and on Day 30. Death: fatal event resulting from any cause. New MI: defined by electrocardiographic and/or biomarker criteria of myocardial necrosis. Biochemical markers: creatine phosphokinase - myocardial band (CPK-MB) levels and the qualitative troponin-T test.
Measured: End of hospitalization, Day 30
Number of Subjects With Stent Thrombosis and Abrupt Closures During Hospitalization
Abrupt vessel closure and or stent thrombosis: occurrence of vessel closure (no visible antegrade flow of contrast dye occurring after balloon angioplasty) or stent thrombosis determined angiographically.
Measured: End of hospitalization, Day 30
Number of Subjects With Bleeding by Thrombolysis in Myocardial Infarction (TIMI) Criteria
Thrombolysis in myocardial infarction (TIMI) major bleeding: at least a 5-grams per deciliter (g/dL) decrease in hemoglobin, at least a 15 percent (%) decrease in hematocrit, or intracranial bleeding. TIMI minor bleeding: associated with gastrointestinal or genitourinary bleeding, with an absolute decrease in hemoglobin of 4 g/dL or more, or decrease in hematocrit of at least 12%.
Measured: End of hospitalization, Day 30

Timeline

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

Jun 2007Dec 2008

First posted15 Feb 2007 (estimated)
Study startJun 2007
Primary completionDec 2008
Study completionDec 2008

Why it stopped: See termination reason in detailed description.

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 Angina, UnstableStudies 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: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 173 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00435487
Sponsor's protocol ID: A6301079
Status last verified: Oct 2011
First submitted: 13 Feb 2007
Last updated: 17 Oct 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
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Invasive Evaluation and Phenotype-Guided Treatment of ANOCA in Women
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Emergency Department Triage of Patients With Acute Chest Pain Based on the ESC 0/1-hour Algorithm (PRESC1SE-MI)
Acute Chest Pain, NSTEMI - Non-ST Segment Elevation MI

All Angina, Unstable trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Randomized Phase IV Open Label Comparative Study Of Dalteparin vs Unfractionated Heparin In High Risk Patients Of Non-ST Elevation Acute Coronary Syndromes Intended For Early Invasive Strategy
ClinicalTrials.gov ID: NCT00435487
Acronym / sponsor ID: A6301079
Conditions: Angina, Unstable, Myocardial Infarction
Keywords: Non-ST Elevation Acute Coronary Syndromes coronary interventions
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: See termination reason in detailed description.
Enrolment: 173 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jun 2007
Primary completion: Dec 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 15 Feb 2007 (estimated)
Results: Posted 27 Jan 2010

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

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
A	Experimental	Drug: Dalteparin ( Fragmin)
B	Active comparator	Drug: Unfractionated heparin

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients more than 18 years
Ischemic pain of more than 10 minutes within 24 hours before enrollment
At least two of the following three risk factors : Age more than 60 years ( or more than 50 in case of diabetics), Raised cardiac enzyme levels, abnormal ECG findings

Key exclusion criteria (5 listed)

Contraindications to use of anticoagulants
Active bleeding or abnormal coagulation tests
Ischemic stroke within last 6 months or hemorrhagic stroke
Lumbar or spinal puncture within last 48 hours
S creatinine levels more than 2

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
Dalteparin ( Fragmin)Dalteparin will be administered at a dose of 120 IU/kg (international units per kilogram) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours.	Drug	A
Unfractionated heparinUnfractionated heparin will be given intravenously according to a weight-adjusted nomogram (bolus of 60 U/kg [units per kilogram] and initial infusion of 12 U/kg/h [units per kilogram per hour]).	Drug	B

Primary outcome

Number of Subjects With Death or Non-fatal Myocardial Infarction Through and Up to Day 30
Time frame: Baseline to Day 30
Death or non-fatal myocardial infarction (MI) after receiving 48 hours of study medication (event date - first dose date) on or before day 30 from baseline. Death: fatal event resulting from any cause. New MI: electrocardiographic (ECG) and or biomarker criteria of myocardial necrosis. Biochemical markers: creatine phosphokinase - myocardial band (CPK-MB) levels and the qualitative troponin-T test.

5 secondary outcomes

Number of Subjects With Stroke
Time frame: End of hospitalization, Day 30
Number of Subjects With Recurrent Angina With or Without Need for Hospitalization and or Revascularization
Time frame: End of hospitalization, Day 30
Number of Subjects With Death or Non-fatal Myocardial Infarction (MI), Computed Separately, at End of Hospitalization and 30 Days
Time frame: End of hospitalization, Day 30
Number of Subjects With Stent Thrombosis and Abrupt Closures During Hospitalization
Time frame: End of hospitalization, Day 30
Number of Subjects With Bleeding by Thrombolysis in Myocardial Infarction (TIMI) Criteria
Time frame: End of hospitalization, Day 30

Results and safety

Results posted to the registry on 27 Jan 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm A: Dalteparin	88	76
Arm B: Unfractioned Heparin (UFH)	86	71

Primary outcome: Number of Subjects With Death or Non-fatal Myocardial Infarction Through and Up to Day 30

Time frame: Baseline to Day 30. Number. Unit: participants

Measure	Arm A: Dalteparin n = 79	Arm B: Unfractioned Heparin (UFH) n = 78
Death	2	4
Non-fatal Myocardial Infarction	2	1
Death or Non-fatal Myocardial Infarction	4	5

Arm A: Dalteparin vs Arm B: Unfractioned Heparin (UFH): Difference in proportion: -2.60 (95% CI -8.59 to 3.40), upper limit of 95% CI <= 10%
Arm A: Dalteparin vs Arm B: Unfractioned Heparin (UFH): Difference in proportion: 1.25 (95% CI -3.02 to 5.52), upper limit of 95% CI <= 10%
Arm A: Dalteparin vs Arm B: Unfractioned Heparin (UFH): Difference in proportion: -1.35 (95% CI -8.62 to 5.93), upper limit of 95% CI <= 10%

Population analysed: Evaluable population: all subjects who took study medication for at least 48 hours from baseline and had complete information on the endpoint.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm A: Dalteparin	4 of 88 (4.5%)	58 of 88 (65.9%)	Not reported
Arm B: Unfractioned Heparin (UFH)	13 of 83 (15.7%)	59 of 83 (71.1%)	Not reported

Limitations and caveats (from the sponsor): This study was terminated due to insufficient recruitment of subjects.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2011.
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 Angina, Unstable

RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
Invasive Evaluation and Phenotype-Guided Treatment of ANOCA in Women
ANOCA - Angina With Non-obstructive Coronary Arteries, Coronary Microvascular Dysfunction (CMD)
RecruitingObservational study
Analysis of Life-threatening ARrhythMias After Acute Coronary Syndrome
Acute Coronary Syndromes (ACS), Ventricular Tachycardia (VT)
RecruitingObservational study
Gangwon PCI Prospective Registry
Coronary Artery Disease, Ischemic Heart Disease (IHD)
Active, not recruiting
Emergency Department Triage of Patients With Acute Chest Pain Based on the ESC 0/1-hour Algorithm (PRESC1SE-MI)
Acute Chest Pain, NSTEMI - Non-ST Segment Elevation MI

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

8 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 Dalteparin ( Fragmin) and Unfractionated heparin in people with Angina, Unstable and Myocardial Infarction, run by Pfizer at 8 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 17 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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.

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?

Yes. Results are posted in the registry (first posted 27 Jan 2010). 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 Subjects With Death or Non-fatal Myocardial Infarction Through and Up to Day 30 (time frame: Baseline to Day 30). 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 NCT00435487.

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 17 Oct 2011.